BD SAFETYGLIDE¿ NEEDLE
Report
- Report Number
- 1213809-2023-01068
- Event Type
- Malfunction
- Date Received
- September 27, 2023
- Date of Event
- August 8, 2023
- Report Date
- January 23, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- UDI-DI
- 30382903059165
- PMA / PMN Number
- K951254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
CORRECTION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 7 OF THE BD SAFETYGLIDE¿ NEEDLE WERE CLOGGED THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THREE (3) LPNS BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED.
PR (B)(4) FOLLOW UP: IT WAS REPORTED THE NEEDLES MALFUNCTIONED. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD WAS REVIEWED FOR PROVIDED MATERIAL NUMBER 305916, LOT 2024138. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2024138 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION OF THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH NUMBERS. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO ENSURE THE NEEDLE LUBRICATION IS APPLIED APPROPRIATELY. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H10 NARRATIVE.
E.4. FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH# [MW5144840]. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT 7 OF THE BD SAFETYGLIDE¿ NEEDLE WERE CLOGGED THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THREE (3) LPNS BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED.
NO ADDITIONAL INFORMATION RECEIVED. MAT#: 305916, BATCH#: 2024138. IT WAS REPORTED BY CUSTOMER THAT THREE (3) LPNS (LICENSED PRACTICAL NURSES) BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED. THIS WAS THE 25G X 1-INCH SAFETYGLIDE NEEDLE. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THREE (3) LPNS BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED. THIS WAS THE 25G X 1 INCH SAFETYGLIDE NEEDLE. REFERENCE REPORTS: MW5144841, MW5144842, MW5144843, MW5144844, MW5144845, MW5144846. 20SEP2023. ADDITIONAL INFORMATION RECEIVED FOR PR (B)(4) STATES, ¿WHEN MEDICINE WAS DRAWN UP IN THE SYRINGE & NURSE WENT TO ADVANCE THE PLUNGER IT WOULD NOT ADVANCE.¿.
IT WAS REPORTED THAT 7 OF THE BD SAFETYGLIDE¿ NEEDLE WERE DAMAGED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THREE (3) LPNS BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTION - TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832506 | BD SAFETYGLIDE¿ NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 2024138 | 30382903059165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |