BD SAFETYGLIDE¿ NEEDLE
Report
- Report Number
- 1213809-2023-00546
- Event Type
- Malfunction
- Date Received
- May 22, 2023
- Date of Event
- April 21, 2023
- Report Date
- April 16, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- UDI-DI
- 00382903059171
- PMA / PMN Number
- K951254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?YES. D10: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY SIX SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. FOUR SAMPLES RECEIVED IN SEALED PACKAGES AND TWO SAMPLES RECEIVED IN OPENED PACKAGING BLISTERS. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT FIVE SAMPLES HAVE 21G X 1 1/2" NEEDLE AND ONE SAMPLE WHICH CAME IN AN OPENED PACKAGING BLISTER HAVE 23G X 1" NEEDLE. BASED ON THE INVESTIGATION WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR 10000690801. THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: SAFETYGLIDE. DEVICE FAILURE: MIXED PRODUCT/LOTS.
H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT A NEEDLE WITH A BLUE HUB WAS FOUND IN THE PACK OF GREEN-HUBBED BD SAFETYGLIDE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD NEEDLES USUALLY HAVE A GREEN PLASTIC HOUSING BEARING THE METALLIC CANNULA. A NEEDLE WITH A BLUE HOUSING WAS FOUND WITHIN THE BATCH."
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT A NEEDLE WITH A BLUE HUB WAS FOUND IN THE PACK OF GREEN-HUBBED BD SAFETYGLIDE¿ NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD NEEDLES USUALLY HAVE A GREEN PLASTIC HOUSING BEARING THE METALLIC CANNULA. A NEEDLE WITH A BLUE HOUSING WAS FOUND WITHIN THE BATCH."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863161 | BD SAFETYGLIDE¿ NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 1215754 | 00382903059171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |