BD SAFE-CLIP
Report
- Report Number
- 2243072-2021-02828
- Event Type
- Malfunction
- Date Received
- November 24, 2021
- Date of Event
- October 29, 2021
- Report Date
- January 24, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 00382903282357
- PMA / PMN Number
- K943683
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-12-31 H6: INVESTIGATION SUMMAR CUSTOMER RETURNED A SINGLE SAFECLIP NEEDLE TRIMMER FROM LOT 9192035. THERE WERE NO IMMEDIATELY OBSERVABLE DEFECTS TO THE TRIMMER. WHILE NEEDLE REMNANTS COULD BE HEARD RATTLING IN THE DEVICE, THERE WAS NO INDICATION THAT THE SAFECLIP HAD LOST FUNCTIONALITY. THE NEEDLE PORT DID NOT SHOW SIGNS OF WEAR UNDER MAGNIFICATION. THE SAFECLIP WAS TESTED ON A SPARE PEN NEEDLE AND WAS FOUND TO BE ABLE TO TRIM NEEDLES WITHOUT DIFFICULTY. NO DEFECTS WERE OBSERVED AND THE DEVICE FUNCTIONS AS INTENDED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE NEEDLE TRIMMER NOT TRIMMING NEEDLES. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.
H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9192035. H3 OTHER TEXT : SEE H10.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED BD SAFE-CLIP WOULD NOT CLIP THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE BD SAFE CLIP NEEDLE CLIPPER DOES NOT CLIP THE ENTIRE NEEDLE. SHE STATED THAT A PART OF THE NEEDLE REMAINS ON THE SYRINGE AFTER CLIPPING."
IT WAS REPORTED BD SAFE-CLIP WOULD NOT CLIP THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE BD SAFE CLIP NEEDLE CLIPPER DOES NOT CLIP THE ENTIRE NEEDLE. SHE STATED THAT A PART OF THE NEEDLE REMAINS ON THE SYRINGE AFTER CLIPPING."
IT WAS REPORTED BD SAFE-CLIP WOULD NOT CLIP THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE BD SAFE CLIP NEEDLE CLIPPER DOES NOT CLIP THE ENTIRE NEEDLE. SHE STATED THAT A PART OF THE NEEDLE REMAINS ON THE SYRINGE AFTER CLIPPING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1766694 | BD SAFE-CLIP | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON | 328235 | 9192035 | 00382903282357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |