BD SAFETYGLIDE
Report
- Report Number
- 1213809-2023-01540
- Event Type
- Malfunction
- Date Received
- January 17, 2024
- Date of Event
- December 19, 2023
- Report Date
- August 19, 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
- AK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBER INCLUDES 2007149 AND OTHER EXPIRATION DATE INCLUDES 2026-12-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2022-01-07.
(B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION. FIVE HUNDRED AND FIVE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ONE HUNDRED AND TWENTY-EIGHT SAMPLE WERE RANDOMLY SELECTED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ONE HUNDRED AND NINETEEN SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW, EIGHT SAMPLES FROM LOT 2024137 AND ONE SAMPLE FROM LOT 2007149 DID NOT EXPEL THE SOLUTION; THESE NEEDLES ARE CLOGGED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 2024137, 1112721, 2007149 AND 1152501. 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. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. 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. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED.
PR 9432664 FOLLOW UP REPORT FOR CORRECTION. LOT NUMBER 202437 INITIALLY REPORTED BY CUSTOMER WAS INCORRECT AND MISSING A DIGIT, CORRECT LOT NUMBER WAS NOT KNOWN WITH INITIAL MDR. VALID LOT NUMBER 2024137 WAS SUBSEQUENTLY IDENTIFIED AND CONFIRMED TO BE THE CORRECT LOT NUMBER. H3 OTHER TEXT : SEE NARRATIVE BELOW
(B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATIONNO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, 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. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. 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. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLES WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FAILURE MODE: CLOGGED/BLOCKED" ADDITIONAL INFORMATION RECEIVED ON 01/04/2023 I FIND IT VERY FRUSTRATING THAT I HAVE TO RE LIST ALL THE LOT INFORMATION AS I HAVE ALREADY SHARED IT WITH THE REP THAT I SPOKE TO ON THE PHONE. THIS HAS HAPPENED VARIOUS DATES OVER THE FLU SEASON 2023 ON MULTIPLE OCCASIONS. FOR REF (B)(4) BD SAFETY GLIDE 25G 1IN NEEDLES. LOT 202437¿400 NEEDLES LOT 1112721 50 NEEDLES LOT 2007149 50 NEEDLES. THIS WAS DISCOVERED WHEN USING FOR INJECTION OF VACCINE THE FLOW WAS NEARLY FULLY OBSTRUCTED. ONE PATIENT HAD TO BE PUNCTURED TWICE BECAUSE THE NEEDLE HAD TO BE REPLACED. SINCE THEN WE HAVE TESTED THE FLOW OF EVERY NEEDLE BEFORE USING.
NO ADDITIONAL INFORMATION WAS PROVIDED.
NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1774362 | BD SAFETYGLIDE | SAFETYGLIDE NEEDLES | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 2024137 | 30382903059165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |