BD SAFETYGLIDE
Report
- Report Number
- 1213809-2024-00025
- Event Type
- Malfunction
- Date Received
- January 23, 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
PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION. D SECTION: OTHER LOT NUMBER INCLUDES 1112721, EXPIRATION DATE INCLUDES 03-31-2026. 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.
B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
PR (B)(4) FOLLOW UP REPORT FOR ADDITIONAL INFORMATION. ADDITIONAL LOT #2007149 WAS PROVIDED BY CUSTOMER.
PR (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION. NO 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.
(B)(4) FOLLOW UP REPORT FOR CORRECTION. MFR REPORT # 1213809-2024-00025 WAS SUBMITTED IN ERROR. ADDITIONAL LOT #2007149 WAS PROVIDED BY CUSTOMER AND SUBMITTED WITH SUPPLEMENTAL/FOLLOW-UP 1.
NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER: "CLOGGED/BLOCKED" LABEL CASE 25X1 SG CE 305916 DG1310-06 PRODUCTCOMPLAINT YES 5 BOXES ADDITIONAL INFORMATION PROVIDED ON 01/04/24: 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 305916 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. THE ADDRESS FOR THE RETURN LABEL IS CVS 1515 COUNTY B RD W, ROSEVILLE, MN 55113
ADDITIONAL LOT # 2007149 PROVIDED BY CUSTOMER.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1855394 | BD SAFETYGLIDE | SAFETYGLIDE NEEDLES | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 2007149 | 30382903059165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |