NA 2N1333Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00085412475394), received between Jul 8, 2019 and Sep 15, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (K132734); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT FOUR (4) NON-DEHP STANDARD BORE CATHETER EXTENSION SETS LEAKED; FURTHER DESCRIBED AS "IT ISN¿T GETTING A GOOD SEAL". THE ISSUE WAS OBSERVED WHEN TIGHTENING THE END OF THE SETS WITH AN INTRAVENOUS (IV) CATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760503 ↗
• MalfunctionJan 4, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT A NON-DEHP STANDARD BORE CATHETER EXTENSION SET DID NOT HAVE A RETRACTABLE COLLAR. THIS WAS IDENTIFIED AFTER CONNECTING THE SET WITH A BD INSYTE AUTOGUARD 20G 1.88 UNDER ULTRASOUND GUIDANCE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097143 ↗
• MalfunctionDec 29, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT A NON-DEHP STANDARD BORE CATHETER EXTENSION SET DOES NOT HAVE A RETRACTABLE COLLAR. THIS WAS OBSERVED AFTER CONNECTING THE EXTENSION SET TO A BD INSYTE AUTOGUARD 20G 1.88 (NON-BAXTER). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069044 ↗
• MalfunctionJun 30, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ONE HUNDRED SIXTY-FOUR (164) NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE DEFECTIVE; FURTHER DESCRIBED AS THE PACKAGING WAS FALLING APART IN PIECES (DETERIORATED). THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14876415 ↗
• MalfunctionSep 23, 2021No Flow; No Flow

  IT WAS REPORTED THAT AT LEAST FOUR (4) NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE NOT IRRIGATING AND WERE NOT ABLE TO FLUSH. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519061 ↗
• MalfunctionSep 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A NON-DEHP STANDARD BORE CATHETER EXTENSION SET LEAKED. DURING PRIMING, "THE IV FLUID LEAKED AROUND AND WOULD NOT FLOW THROUGH TUBING". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484692 ↗
• MalfunctionSep 13, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE ¿BLOCK/CLOGGED¿ AND WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT IT WAS IMPOSSIBLE TO EMPTY THE SETS UNLESS BY INJECTING LIQUID WITH AN UNSPECIFIED SYRINGE BY APPLYING STRONG PRESSURE ON THE PLUNGER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465708 ↗
• MalfunctionSep 13, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE ¿BLOCK/CLOGGED¿ AND WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT IT WAS IMPOSSIBLE TO EMPTY THE SETS UNLESS BY INJECTING LIQUID WITH AN UNSPECIFIED SYRINGE BY APPLYING STRONG PRESSURE ON THE PLUNGER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465705 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBERS OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE NOT WORKING. THE EVENT WAS FURTHER DESCRIBED AS; WHEN PRIMING AN INTRAVENOUS (IV) FLUID, THE IV FLUID WOULD NOT RUN THROUGH THE TUBING AND WOULD LEAK AROUND. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464514 ↗
• MalfunctionSep 13, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE ¿BLOCK/CLOGGED¿ AND WOULD NOT FLOW. IT WAS FURTHER REPORTED THAT IT WAS IMPOSSIBLE TO EMPTY THE SETS UNLESS BY INJECTING LIQUID WITH AN UNSPECIFIED SYRINGE BY APPLYING STRONG PRESSURE ON THE PLUNGER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460393 ↗
• MalfunctionSep 10, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT FOUR (4) NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE BLOCK/CLOGGED. IT WAS FURTHER REPORTED THAT IT WAS IMPOSSIBLE TO EMPTY THE SET UNLESS BY INJECTING LIQUID WITH AN UNSPECIFIED SYRINGE BY APPLYING STRONG PRESSURE ON THE PLUNGER. THIS WAS IDENTIFIED DURING/AFTER USE (NOT FURTHER SPECIFIED). THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456949 ↗
• MalfunctionSep 10, 2021No Flow; No Flow

  IT WAS REPORTED THAT A NON-DEHP STANDARD BORE CATHETER EXTENSION SET WOULD NOT FLOW. IT WAS FURTHER DESCRIBED AS FLUIDS WOULD NOT ALLOW TO COME DOWN THE IV TUBING. THIS ISSUES WAS IDENTIFIED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456564 ↗
• MalfunctionSep 10, 2021Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WOULD NOT FLOW AND SUBSEQUENTLY LEAKED. IT WAS FURTHER REPORTED DURING PRIMING, "THE FLUID WOULD NOT RUN THROUGH" AND THE "IV FLUID LEAKED AROUND WOULD NOT FLOW THROUGH THE TUBING". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454419 ↗
• MalfunctionSep 10, 2021Fluid/Blood Leak; No Flow; Fluid/Blood Leak; No Flow

  IT WAS REPORTED AN UNSPECIFIED QUANTITY OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WOULD NOT FLOW AND SUBSEQUENTLY LEAKED. IT WAS FURTHER REPORTED DURING PRIMING, "THE FLUID WOULD NOT RUN THROUGH" AND THE "IV FLUID LEAKED AROUND WOULD NOT FLOW THROUGH THE TUBING". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453644 ↗
• MalfunctionSep 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBERS OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE NOT WORKING. THE EVENT WAS FURTHER DESCRIBED AS; WHEN PRIMING AN INTRAVENOUS (IV) FLUID, THE IV FLUID WOULD LEAK AROUND. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425836 ↗
• MalfunctionSep 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBERS OF NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE NOT WORKING. THE EVENT WAS FURTHER DESCRIBED AS; WHEN PRIMING AN INTRAVENOUS (IV) FLUID, THE IV FLUID WOULD LEAK AROUND. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425833 ↗
• MalfunctionAug 24, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT TEN (10) NON-DEHP STANDARD BORE CATHETER EXTENSION SETS WERE ¿BLOCK/CLOGGED¿. IT WAS FURTHER REPORTED THAT IT WAS IMPOSSIBLE TO EMPTY THE SET UNLESS BY INJECTING LIQUID WITH AN UNSPECIFIED SYRINGE BY APPLYING STRONG PRESSURE ON THE PLUNGER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360254 ↗
• MalfunctionJun 8, 2020Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LUER OF A NON-DEHP STANDARD BORE CATHETER EXTENSION SET BROKE OFF. IT WAS FURTHER REPORTED THAT THE CLAMP "CUT THROUGH" THE TUBING. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10130698 ↗
• MalfunctionOct 9, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LUER HUB OF A NON-DEHP STANDARD BORE CATHETER EXTENSION SET WOULD EASILY PULL APART FROM THE TUBING WHICH CAUSED A VENOUS BLOOD LEAK. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171686 ↗
• MalfunctionJul 8, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MALE LUER LOCK OF A STANDARD BORE CATHETER EXTENSION SET WAS LOOSE AT THE POINT WHERE IT WAS BONDED TO THE REST OF THE EXTENSION SET. THIS EVENT RESULTED IN A LEAK DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132734. One submission often covers many models, so check the product and lot details in each record.

• Z-1102-2021 · Dec 21, 2020 · Terminated
  Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended
• Z-0132-2016 · May 21, 2015 · Terminated
  ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT