BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G
Report
- Report Number
- 1213809-2022-00849
- Event Type
- Malfunction
- Date Received
- October 31, 2022
- Date of Event
- October 13, 2022
- Report Date
- November 10, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- UDI-DI
- 00382903059164
- PMA / PMN Number
- K951254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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: 28-OCT-2022. H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT THE NEEDLES WERE CLOGGED. TO AID IN THE INVESTIGATION, TEN SAMPLES FROM LOT 2024138 WITH NO PACKAGING BLISTERS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NO SAMPLES WERE RETURNED FROM LOT NUMBER 1239304. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. EIGHT SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. TWO SAMPLES DID NOT EXPEL THE SOLUTION; THESE NEEDLES ARE CLOGGED. BASED ON THE QUALITY TEAM¿S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT CLOGGED NEEDLE CAN BE TRACED TO THE MANUFACTURING PROCESS. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1239304 AND 2024138. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER OF A PREFILLED SYRINGE WAS NOT ABLE TO BE DEPRESSED WHEN USING A BD SAFETY GLIDE NEEDLE ATTACHED. HOWEVER, YESTERDAY (B)(6) 2022 I ENCOUNTERED 8 NEEDLES FROM LOT #2024138 AFTER APPLYING THE NEEDLE TO THE VACCINE PRODUCT THE PLUNGER IS VERY DIFFICULT TO DEPRESS . I AM UNABLE TO EXPEL THE AIR BUBBLE WITHOUT APPLYING EXTRA FORCE AND RISK LOSING VACCINE . I WOULD ALSO NOT TRY TO INJECT THE PATIENT WITH EXCESSIVE FORCE , SO THEREFORE I CHANGE THE NEEDLE UNTIL I FIND ONE THAT WORKS .
IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PLUNGER OF A PREFILLED SYRINGE WAS NOT ABLE TO BE DEPRESSED WHEN USING A BD SAFETY GLIDE NEEDLE ATTACHED. HOWEVER, YESTERDAY (B)(6) 2022 I ENCOUNTERED 8 NEEDLES FROM LOT #2024138 AFTER APPLYING THE NEEDLE TO THE VACCINE PRODUCT THE PLUNGER IS VERY DIFFICULT TO DEPRESS . I AM UNABLE TO EXPEL THE AIR BUBBLE WITHOUT APPLYING EXTRA FORCE AND RISK LOSING VACCINE . I WOULD ALSO NOT TRY TO INJECT THE PATIENT WITH EXCESSIVE FORCE , SO THEREFORE I CHANGE THE NEEDLE UNTIL I FIND ONE THAT WORKS .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 461414 | BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 2024138 | 00382903059164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |