NA 00711811 (UDI 00816765011898)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00816765011898), received between Jul 10, 2019 and Sep 11, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2020Activation Problem

  STERIS ENDOSCOPY RECEIVED USER FACILITY MEDWATCH REPORT NUMBER MW5095298, WHICH REPORTED THAT A CARR-LOCKE INJECTION NEEDLE FAILED TO DEPLOY.

  Patient problems: Insufficient Information

  MAUDE report 10521132 ↗
• MalfunctionJan 3, 2020Activation Problem

  REFERENCE USER FACILITY MEDWATCH # (B)(4), WHICH REPORTED THE CARR-LOCKE INJECTION NEEDLE FAILED TO DEPLOY DURING PROCEDURAL USE. THE DEVICE WAS IMMEDIATELY REPLACED WITH ANOTHER CARR-LOCKE INJECTION NEEDLE, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO INJURIES ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9548275 ↗
• MalfunctionOct 23, 2019Defective Component

  THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH # (B)(4) THAT THE CARR-LOCKE INJECTION NEEDLE DID NOT FULLY ENGAGE DURING A PATIENT PROCEDURE. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9225734 ↗
• MalfunctionOct 4, 2019Defective Component

  US ENDOSCOPY RECEIVED USER FACILITY MEDWATCH #(B)(4) REPORTING THAT DURING A PATIENT PROCEDURE THE LOCKING FEATURE ON THEIR CARR-LOCK INJECTION NEEDLE COULD NOT BE ENGAGED. THE FUNCTION OF THE LOCKING FEATURE IS TO MAINTAIN THE NEEDLE IN AN EXTENDED POSITION. THE USER MANUALLY EXTENDED THE NEEDLE AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE SAME DEVICE. THERE WAS NO REPORT OF HARM TO THE PATIENT OR USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9155747 ↗
• MalfunctionAug 27, 2019Loose or Intermittent Connection

  US ENDOSCOPY INJECTION NEEDLE WOULD NOT 'LOCK'. NURSE HELD IN POSITION TO CONCLUDE PROCEDURE. NO HARM CAME TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935446 ↗
• MalfunctionAug 20, 2019Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED USER NEEDLE STICK INJURIES FOLLOWING USE OF THE CARR-LOCKE INJECTION NEEDLE, ESTIMATED TO HAVE OCCURRED THREE TIMES IN THE PAST YEAR. THE FACILITY PROTOCOL FOR NEEDLE STICK INJURY, WHICH INCLUDES PATIENT AND USER BLOOD SAMPLING, WAS FOLLOWED AND IT WAS DETERMINED NO FURTHER TREATMENT WAS NEEDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8909862 ↗
• MalfunctionJul 10, 2019Insufficient Device Problem Information

  REFERENCE USER FACILITY MEDWATCH REPORT #5086388. THERE WERE NO INJURIES ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8778442 ↗