BD SAFETYGLIDE¿ NEEDLE
Report
- Report Number
- 1213809-2022-00653
- Event Type
- Malfunction
- Date Received
- September 29, 2022
- Date of Event
- September 7, 2022
- Report Date
- July 2, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- UDI-DI
- 00382903059164
- PMA / PMN Number
- K951254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES FROM LOTS 2024137 AND 2014639 WERE BLOCKED DURING THE VACCINE ADMINISTRATION. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2024137. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. H.4. DEVICE MANUFACTURE DATE: 24-JAN-2022. D.4. MEDICAL DEVICE LOT #: 2014639. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026. H.4. DEVICE MANUFACTURE DATE: 14-JAN-2022.
SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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 NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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 AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING THE VACCINE ADMINISTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A FEW STORES THAT RECEIVED A LOT OF BD SAFETY GLIDES WITH A PRODUCT ISSUE (LOT NUMBER 2024137). THEY ARE NOT ABLE TO PROPERLY ADMINISTER VACCINE WITH THIS LOT AS THEY ATTACH THE NEEDLE AND ARE NOT ABLE TO EXPEL AIR FROM THE PREFILLED SYRINGE. THEY ARE STATING THAT THEY ENCOUNTER RESISTANCE. TWO STORES AND TWO PHARMACISTS HAVE VALIDATED THE LOT NUMBER AND SIMILAR CONCERN."
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES FROM LOTS 2024137 AND 2014639 WERE BLOCKED DURING THE VACCINE ADMINISTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE A FEW STORES THAT RECEIVED A LOT OF BD SAFETY GLIDES WITH A PRODUCT ISSUE (LOT NUMBER 2024137). THEY ARE NOT ABLE TO PROPERLY ADMINISTER VACCINE WITH THIS LOT AS THEY ATTACH THE NEEDLE AND ARE NOT ABLE TO EXPEL AIR FROM THE PREFILLED SYRINGE. THEY ARE STATING THAT THEY ENCOUNTER RESISTANCE. TWO STORES AND TWO PHARMACISTS HAVE VALIDATED THE LOT NUMBER AND SIMILAR CONCERN."
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1767974 | BD SAFETYGLIDE¿ NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL SYSTEMS | SEE H10 | 00382903059164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |