BD SAFETYGLIDE
Report
- Report Number
- 1213809-2024-00870
- Event Type
- Malfunction
- Date Received
- November 24, 2024
- Date of Event
- October 30, 2024
- Report Date
- December 9, 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
- IL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 2003405. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT 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.
MATERIALS: 305916, BATCH#: 2003405. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT BLOCKAGE. ON CALL WITH CUSTOMER REGARDING (B)(4) HE NOTED OTHER CONTACTS WITHIN HIS GROUP FOR FLU CLINIC HAVE STATED THEY HAVE HAD BLOCKAGE ISSUES WITH 1 INCH NEEDLES. HE DID NOT HAVE ANY ADDITIONAL DETAILS ON PRODUCT CODE OR DETAILS OF OCCURRENCES. HE STATED HE WILL PROVIDE CONTACT FOR THESE ISSUES THAT WE CAN REACH OUT TO FOR MORE DETAILS. I WILL PROVIDE UPDATED CONTACT TO REACH OUT TO ONCE XXXX PROVIDES THE INFORMATION. NEW NOTE ADDED SINCE PIR SUBMISSION- CUSTOMER CONTACT XXXX XXXX REACHED OUT TO PROVIDE CORRECT CONTACTS FOR THIS CONCERN, PLEASE REACH OUT TO XXXX AND XXX XXXX AT [email protected] AND [email protected]. I WAS LOOPED INTO AN EMAIL WITH THEM AND HAVE FOLLOWED UP TO ASK FOR DETAILS BUT HAVE NOT YET RECEIVED A RESPONSE. CUSTOMER XXX XXXX HAS RESPONDED TO OUTREACH NOTED ABOVE, PLEASE UPDATE RECORD TO INCLUDE INFORMATION BELOW. WHAT IS THE BD MATERIAL NUMBER IMPACTED? 1¿ 25G BD SAFETYGLIDE NEEDLES (REF: 305916). ARE THE IMPACTED LOT NUMBERS AVAILABLE? 2003405, EXPIRATION DATE 12/31/2026. HOW MANY TIMES DID THE ISSUE OCCUR? ARE THE DATES THE ISSUE OCCURRED AVAILABLE? MULTIPLE OCCURRENCES, THERE WAS ONE BOX WITH ALMOST 1/2 NEEDLES FAULTY WAS IT JUST BLOCKAGE SEEN WITH THIS PRODUCT, OR DID YOU EXPERIENCE LEAKAGE SHOOTING OUT THE SIDE OF THE NEEDLE HUB AS WELL? JUST BLOCKAGE. WERE THERE ANY ADVERSE EVENTS THAT OCCURRED DUE TO THIS ISSUE? WE'VE HAD RNS HAVING TO STICK PATIENTS 2X BECAUSE THE VACCINE WON'T COME OUT. ARE SAMPLES, PHOTOS, OR VIDEO OF THE ISSUE AVAILABLE FOR INVESTIGATION REVIEW? NO.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2623018 | BD SAFETYGLIDE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 2003405 | 30382903059165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |