Site-Rite 900013B01Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741037771), received between Mar 24, 2017 and Mar 25, 2026 — classified as 55 malfunctions.

The most frequently reported specific device problem is “Defective Component” (19 reports).

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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Product Quality Problem

  IT WAS REPORTED THAT DURING PICC CATHETER INSERTION, A HOLE WAS DISCOVERED IN THE STERILE PROTECTIVE COVER WHILE APPLYING THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688224 ↗
• MalfunctionJan 29, 2026Product Quality Problem

  IT WAS REPORTED THE PROBE PROTECTIVE SLEEVE VISIBLE TO THE NAKED EYE HAS A SMALL DAMAGE, FOR THE REPLACEMENT OF THE NEW KIT, DAMAGED KIT ON-SITE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209131 ↗
• MalfunctionJun 26, 2025Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER CAN PULL NEEDLE THROUGH THE NEEDLE GUIDE. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES. ON 06/10/2025 - DURING EVALUATION OF THE THREE RETURNED DEVICES, PIECES OF PLASTIC WERE NOTED IN THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342676 ↗
• MalfunctionJun 4, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE ULTRASOUND KIT WAS USED INTRAOPERATIVELY, IT WAS FOUND THAT THE MEMBRANE OF THE KIT WAS TORN AND UNUSABLE, SO THE KIT WAS REPLACED WITH A NEW ONE ON THE OPERATING TABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145488 ↗
• MalfunctionFeb 5, 2025Defective Component; Defective Component

  IT WAS REPORTED, "THE PLASTIC SLEEVE INSIDE BROKE WHEN I PUT IT ON." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317658 ↗
• MalfunctionNov 26, 2024Defective Component; Defective Component

  IT WAS REPORTED, THE PACKAGING OF THE NEEDLE GUIDE FRAME IS DAMAGED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782759 ↗
• MalfunctionJul 18, 2024Defective Component; Defective Component

  IT WAS REPORTED OPENED THE PACKAGE AND FOUND THE ULTRASONIC PROTECTIVE COVER BROKEN. USE OF DEVICE WAS DISCONTINUED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778793 ↗
• MalfunctionMay 1, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, "AT 13:37 ON (B)(6) 2024, PICC CATHETERIZATION WAS PERFORMED FOR THE PATIENT, AND IT WAS FOUND THAT THERE WAS RESIDUE ON THE NEEDLE BEVEL AFTER THE PUNCTURE NEEDLE WAS USED THROUGH THE NEEDLE GUIDE DEVICE, SO THE NURSE IMMEDIATELY USED A SYRINGE CONTAINING NORMAL SALINE TO FLUSH THE NEEDLE, AND CONTINUED TO PUNCTURE AFTER RINSING, AND THE IRRIGATED NEEDLE WAS HUNG WITH WATER BEADS, WHICH MADE THE PUNCTURE DIFFICULT, AND THE PUNCTURE WAS COMPLETED AT 13:50." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220561 ↗
• MalfunctionMar 1, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED BY THE CUSTOMER THE TOP OF THE STERILE PROTECTIVE COVER OF THE ULTRASOUND PROBE IN THE ULTRASOUND VASODILATION KIT IS NOT SEALED, WHICH POSES A RISK OF CONTAMINATION AND NEEDS TO BE REPLACED WITH A NEW KIT, RESULTING IN WASTE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18821196 ↗
• MalfunctionJan 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CATHETERIZATION AT FACILITY ON (B)(6). DURING THE 8TH PICC MAINTENANCE AT THE FACILITY ON (B)(6), THE CATHETER CRACKED AND LEAKED. THIS RESULTS IN THE PATIENT BEING RE-CATHETERIZED AND MAINTAINED, THE PATIENT CLAIMS TO BE AFFECTED BY HIS OWN BODY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535690 ↗
• MalfunctionDec 12, 2023Material Frayed; Material Frayed

  IT WAS REPORTED AFTER INSERTION OF THE NEEDLE, THE GUIDE WIRE WAS PASSED. WHEN ATTEMPTING TO REMOVE IT, THE GUIDE FAILED (BROKEN). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311957 ↗
• MalfunctionNov 21, 2023Difficult to Remove; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED PICC CATHETERIZATION (NEW) IS MORE RESISTANT TO RETRACTION WHEN THE CATHETER IS PREFILLED BEFORE USE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187139 ↗
• MalfunctionMay 17, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "WHEN THE SPECIALIST CATHETERIZATION NURSE PERFORMED PICC PUNCTURE AND CATHETERIZATION FOR THE PATIENT, IT WAS FOUND THAT THE GUIDE WIRE COULD NOT NORMALLY GUIDE THE CATHETER INTO THE BLOOD VESSEL. AFTER CHECKING THE GUIDE WIRE, IT WAS FOUND THAT THE FRONT END OF THE GUIDE WIRE WAS MALFORMED AND HYPERTROPHY, WHICH COULD NOT BE USED NORMALLY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950385 ↗
• MalfunctionApr 19, 2023Defective Component; Defective Component

  IT WAS REPORTED "THE STERILE COVER OF THE NEEDLE GUIDE KIT COMES OUT TORN. NO PATIENT INVOLVEMENT, IT WAS USED OTHER UNIT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769495 ↗
• MalfunctionApr 14, 2023Defective Component; Defective Component

  IT WAS REPORTED KIT NEEDLE GUIDE STERILE COVER COMES OUT TORN. NO PATIENT INVOLVEMENT, IT WAS USED OTHER UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747913 ↗
• MalfunctionApr 14, 2023Defective Component; Tear, Rip or Hole in Device Packaging; Defective Component; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN USING THE SITE RITE* NEEDLE GUIDE KITS & ULTRASOUND PROBE COVER KITS, THE NURSE OF THE ONCOLOGY DEPARTMENT III FOUND THAT THE POUCH CONTAINING THE PROBE WAS DAMAGED. CLARIFICATION RECEIVED (B)(6), 2023: THE PROBE COVER WAS DAMAGED, NOT THE PACKAGE/POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16747357 ↗
• MalfunctionSep 20, 2022Defective Component; Defective Component

  IT WAS REPORTED WHEN THE USG SITE RITE 21G SAFETY COVER WAS POSITIONED FOR PICC PLACEMENT, IT WAS NOTICE IT HAS A HOLE. THE SAFETY COVER HAS BEEN DISCARDED BECAUSE PATIENT IN QUARANTINED DUE TO COVID, AND PROCEDURE WAS COMPLETED USING A NEW DEVICE. (B)(6) 2022 INFORMATION RECEIVED. IN WHICH PART OF PRODUCT WAS HOLE OBSERVED? AT THE PROXIMAL END, WHERE WE PLACED THE PROBE, I NOTICED THE HOLE BECAUSE THE GEL THAT WAS ON THE PROBE LEAKED OUT OF THE COVER. WAS THERE ANY DAMAGE TO ITS PACKAGING? THERE WAS NOT. WAS THERE ANY DAMAGE TO PATIENT? NO, THE HOLE WAS NOTICED WHEN WEARING THE CAPE, BEING REPLACED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459114 ↗
• MalfunctionMar 24, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT "AFTER TAKING A PICC LINE SAMPLE, IT WAS COMPLETELY IMPOSSIBLE TO UNSCREW THE LUER-LOCK VACUTAINER BODY EITHER MANUALLY OR WITH PLIERS. ONLY THE PUMP BODY WAS UNSCREWED, THE LUER-LOCK TIP REMAINING IN PLACE." CLINICAL CONSEQUENCES OBSERVED: THE PICC-LINE HAD TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893573 ↗
• MalfunctionJun 24, 2021Defective Component; Defective Component

  IT WAS REPORTED THE NURSE ON DUTY WAS PREPARING TO PERFORM PICC PUNCTURE FOR THE PATIENT. BEFORE THE PUNCTURE, HE CHECKED THE MATERIALS AND FOUND A HOLE IN THE PROBE SHIELD IN THE ULTRASOUND VASCULAR GUIDANCE KIT. THE GEL LEAKED OUT AND COULD NOT BE USED. THE NEW KIT WAS IMMEDIATELY REPLACED, RESULTING IN WASTE OF CONSUMABLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058585 ↗
• MalfunctionJun 16, 2021Defective Component; Defective Component

  IT WAS REPORTED THE NURSE WAS GOING TO PERFORM PICC PUNCTURE FOR THE PATIENT. BEFORE THE PUNCTURE, HE CHECKED THE MATERIALS. IT WAS FOUND THAT THE PROBE SHIELD IN THE ULTRASOUND VASCULAR GUIDANCE KIT WAS BROKEN. THE GEL LEAKED OUT AND COULD NOT BE USED. THE NEW KIT WAS USED IMMEDIATELY, WHICH CAUSED A WASTE OF CONSUMABLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12013416 ↗
• MalfunctionMay 21, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT THE PROTECTOR OF THE ULTRASOUND PROBE INSIDE THE KIT WAS DAMAGED. AFTER THE ULTRASOUND PROBE COATED WITH COUPLING AGENT WAS COVERED WITH THE PROTECTOR, COUPLING AGENT OVERFLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864086 ↗
• MalfunctionApr 9, 2021Defective Component; Defective Component

  IT WAS REPORTED IN THE PICC CATHETER PLACEMENT FOR THE PATIENT FOR MEDICAL TREATMENT, THE TAIL END OF THE GUIDE WIRE WAS ROUGH AND ENTERED THE BLOOD VESSEL, AND THE CATHETER SHEATH WAS PULLED OUT TO PUNCTURE THE BLOOD VESSEL, RESULTING IN FAILURE OF THE PUNCTURE. IMMEDIATELY SEPARATE THE CATHETER SHEATH AND STABILIZE THE GUIDE WIRE. DID NOT AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642562 ↗
• MalfunctionFeb 9, 2021Delivered as Unsterile Product; Material Puncture/Hole

  IT WAS REPORTED DURING THE SURGICAL PROCEDURE, A POSSIBLE QUALITY DEVIATION WAS EVIDENCED BY THE NURSING TEAM. WHEN OPENING THE PACKAGE AND PLACING THE GEL IN THE PROBE, IT WAS VERIFIED THAT THE COVER WAS PUNCTURED, NOT KEEPING THE PROCEDURE STERILE.

  Patient problems: Insufficient Information

  MAUDE report 11304773 ↗
• MalfunctionSep 18, 2020Defective Component; Defective Component

  IT WAS REPORTED "WE WERE PLACING A PICC AND WENT TO PUT THE PROBE COVER ON AND NOTICED A BIG HOLE IN IT." ADDITIONAL INFO. RECEIVED 08/26/52020: WAS THERE PATIENT HARM REPORTED?: NO IT WAS CAUGHT PRIOR TO USE. A NEW NEEDLE GUIDE/PROBE COVER WAS OPENED.

  Patient problems: No Patient Involvement

  MAUDE report 10554934 ↗
• MalfunctionSep 3, 2020Defective Component; Defective Component

  IT WAS REPORTED THAT DURING PASSAGE OF PICC, WHILE DELIVERING THE ULTRASOUND DEVICE'S PROBE, THE PHYSICIAN NOTICED THAT THE COVER WAS PERFORATED. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 10491044 ↗