NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO
Report
- Report Number
- 1911916-2024-00536
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- June 10, 2024
- Report Date
- March 20, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 50382903020473
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: CONVENTIONAL NEEDLES. DEVICE FAILURE: LABELING CONCERNS.
(B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED ONE BAG WAS MISSING A LABEL, AN INNER BAG WAS DISCOVERED UNSEALED, AND NEEDLES HAD RESIDUALS OF EPOXY ON HUB. TO AID IN THE INVESTIGATION, TWELVE SAMPLES WITH NO PACKAGING AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHYSICAL SAMPLES HAVE AN EPOXY DRIP OVER ON THE NEEDLE HUB. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EXCESSIVE EPOXY COULD OCCUR DURING THE ASSEMBLY PROCESS IF THERE WAS A MISFEEDING OF THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302047, LOT 3271798. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM OF EPOXY EXCESSIVE REPORTED BY THE CUSTOMER IS CONFIRMED.
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION RECEIVED 10-JUN-2024, NEEDLES CAT 9080101/21915233, LOT 3271798/ RA00002494 WERE RECEIVED. DURING THE VISUAL VERIFICATION CHECK, IT WAS DISCOVERED THAT: 1 BAG OF (B)(4) UNITS WAS DISCOVERED WITHOUT IDENTIFICATION LABEL ANOTHER BAG WITH OPEN INNER BAG WAS DISCOVERED, UNSEALED. 12 NEEDLES OUT OF 1250 INSPECTED DISCOVERED WITH RESIDUALS OF EPOXY ON HUB (OUT OF SPEC. ACCORDING TO ANSI 10 AC, 11 RE).
10-JUN-2024, NEEDLES CAT 9080101/21915233, LOT 3271798/ RA00002494 WERE RECEIVED. DURING THE VISUAL VERIFICATION CHECK, IT WAS DISCOVERED THAT: - 1 BAG OF 25,000 UNITS WAS DISCOVERED WITHOUT IDENTIFICATION LABEL - ANOTHER BAG WITH OPEN INNER BAG WAS DISCOVERED, UNSEALED. 12 NEEDLES OUT OF 1250 INSPECTED DISCOVERED WITH RESIDUALS OF EPOXY ON HUB (OUT OF SPEC. ACCORDING TO ANSI 10 AC, 11 RE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2482359 | NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON | 3271798 | 50382903020473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |