NEEDLE M/P BNS 18GA 2-3/4IN W/WINGS
Report
- Report Number
- 2618282-2023-00069
- Event Type
- Malfunction
- Date Received
- August 18, 2023
- Date of Event
- July 19, 2023
- Report Date
- April 24, 2025
- Manufacturer
- BD CARIBE LTD.
- Product Code
- FMI
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2013663 D4. MEDICAL DEVICE EXPIRATION DATE: 31DEC2026 H4. DEVICE MANUFACTURE DATE: 13JAN2022 D4. MEDICAL DEVICE LOT #: 2094756 D4. MEDICAL DEVICE EXPIRATION DATE: 31MAR2027 H4. DEVICE MANUFACTURE DATE: 04APR2022 H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 14-AUG-2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION, THE NEEDLE IS ATTACHED TO A WIRE. NEEDLE WAS NOT CLOGGED NOR BENT. THIS WIRE MEASURED 0.037¿ WHICH IS ADEQUATE FOR AN 18GA NEEDLE. BASED ON THE SAMPLE PROVIDED FROM THE CUSTOMER BD WAS ABLE TO CONFIRM CUSTOMER¿S FAILURE MODE. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE CAN BE DIRECTED TO POSSIBLE HANDLING ISSUES. AS IT IS EXPLAINED IN THE INSTRUCTION FOR USE IN THE CAUTION SECTION TO NEVER PULL GUIDEWIRES OR NEEDLES BACK THROUGH THE BD¿ INTRODUCER NEEDLES. H3 OTHER TEXT : SEE H10.
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 10000690801. 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: ANESTHESIA-SPECIALTY NEEDLES. DEVICE FAILURE: DIFFICULT TO REMOVE.
IT WAS REPORTED THE NEEDLE M/P BNS 18GA 2-3/4IN W/WINGS IS DIFFICULT TO REMOVE FROM THE GUIDEWIRE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING NEEDLE NOT WORKING. DEFECT DESCRIPTION:NEEDLE NOT WORKING ¿ WIRE FROM 7FR CORDIS SHEATH GETTING STUCK IN THE 18G NEEDLE.
IT WAS REPORTED THE NEEDLE M/P BNS 18GA 2-3/4IN W/WINGS IS DIFFICULT TO REMOVE FROM THE GUIDEWIRE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING NEEDLE NOT WORKING. DEFECT DESCRIPTION:NEEDLE NOT WORKING ¿ WIRE FROM 7FR CORDIS SHEATH GETTING STUCK IN THE 18G NEEDLE.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1895287 | NEEDLE M/P BNS 18GA 2-3/4IN W/WINGS | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD CARIBE LTD. | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |