BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
Report
- Report Number
- 1213809-2021-00855
- Event Type
- Malfunction
- Date Received
- January 10, 2022
- Date of Event
- December 7, 2021
- Report Date
- January 24, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- UDI-DI
- 30382903059011
- PMA / PMN Number
- K951254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-04. H6: INVESTIGATION SUMMARY: FOUR SAFETYGLIDE NEEDLES SEALED IN BLISTER PACKS FROM BATCH #1152489 WERE RECEIVED. POTENTIAL ROOT CAUSE FOR THE SAFETY MECHANISM DIFFICULT TO ACTIVATE DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE SAMPLES WERE FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. FURTHER INVESTIGATION WAS PERFORMED AT NEEDLE MANUFACTURING SITE. FOUR SAMPLES WERE RECEIVED IN SEALED BLISTER PACKS . VISUAL INSPECTION WAS PERFORMED. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS TESTED BY ACTIVATING THE SAFETY MECHANISM. ALL OF THEM PASS THE TEST AND SAFETY MECHANISM WORKED CORRECTLY. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. 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.
IT WAS REPORTED THAT BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE HAD A SAFETY MECHANISM THAT WAS DIFFICULT TO ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE SUBSTITUTION USED TO ADMINISTER IMMUNIZATIONS IN PEDS HAS BEEN REPORTED AT FLIMSY AND HARD TO COVER AFTER THE INJECTION OCCURS."
IT WAS REPORTED THAT BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE HAD A SAFETY MECHANISM THAT WAS DIFFICULT TO ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE SUBSTITUTION USED TO ADMINISTER IMMUNIZATIONS IN PEDS HAS BEEN REPORTED AT FLIMSY AND HARD TO COVER AFTER THE INJECTION OCCURS."
IT WAS REPORTED THAT BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE HAD A SAFETY MECHANISM THAT WAS DIFFICULT TO ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE SUBSTITUTION USED TO ADMINISTER IMMUNIZATIONS IN PEDS HAS BEEN REPORTED AT FLIMSY AND HARD TO COVER AFTER THE INJECTION OCCURS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 963581 | BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 305901 | 1152489 | 30382903059011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |