BD PRECISIONGLIDE¿ NEEDLES
Report
- Report Number
- 2243072-2023-00386
- Event Type
- Malfunction
- Date Received
- March 13, 2023
- Date of Event
- February 8, 2023
- Report Date
- March 17, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMI
- UDI-DI
- 00382903051960
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER ON DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAB TECHS ARE HAVING ISSUES WITH THE 16 GAUGE AND 18 GAUGE NEEDLES IN THE LAB. THERE SEEMS TO BE EXCESSIVE GLUE HOLDING THE NEEDLE PARTS TOGETHER. THE GLUE IS OCCASIONALLY FLAKING OFF THE NEEDLE AND LANDING IN THE COMPOUNDING AREA. I DON'T HAVE A LOT OF INFO ABOUT LOT AND EXPIRATION. I WAS TOLD IT HAPPENS MORE WITH THE PURPLE 16 GAUGE NEEDLES THAN THE PINK 18 GAUGE NEEDLES. D1: MEDICAL DEVICE BRAND NAME: BD PRECISIONGLIDE¿ NEEDLES D3: MANUFACTURER NAME: BD MEDICAL (BD WEST) MEDICAL SURGICAL D4: MEDICAL DEVICE CATALOG # 305196 . D4: MEDICAL DEVICE LOT # 2245214. D4: EXPIRATION DATE: 31-OCT-2027. D4: UNIQUE IDENTIFIER (UDI) #: (B)(4). G5: 510K: K021475. H4: DEVICE MANUFACTURE DATE: 02-SEP-2022.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 16MAR2023. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THERE IS EXCESSIVE GLUE HOLDING THE NEEDLE PARTS TOGETHER. TO AID IN THE INVESTIGATION, THREE SAMPLES IN OPENED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS. DURING MANUFACTURING, THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR, THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT. AFTER, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THE EPOXY DRIP OVER ON THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 2245214. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H10.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.
IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER ON DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAB TECHS ARE HAVING ISSUES WITH THE 16 GAUGE AND 18 GAUGE NEEDLES IN THE LAB. THERE SEEMS TO BE EXCESSIVE GLUE HOLDING THE NEEDLE PARTS TOGETHER. THE GLUE IS OCCASIONALLY FLAKING OFF THE NEEDLE AND LANDING IN THE COMPOUNDING AREA. I DON'T HAVE A LOT OF INFO ABOUT LOT AND EXPIRATION. I WAS TOLD IT HAPPENS MORE WITH THE PURPLE 16 GAUGE NEEDLES THAN THE PINK 18 GAUGE NEEDLES.
IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLES EXPERIENCED FOREIGN MATTER ON DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAB TECHS ARE HAVING ISSUES WITH THE 16 GAUGE AND 18 GAUGE NEEDLES IN THE LAB. THERE SEEMS TO BE EXCESSIVE GLUE HOLDING THE NEEDLE PARTS TOGETHER. THE GLUE IS OCCASIONALLY FLAKING OFF THE NEEDLE AND LANDING IN THE COMPOUNDING AREA. I DON'T HAVE A LOT OF INFO ABOUT LOT AND EXPIRATION. I WAS TOLD IT HAPPENS MORE WITH THE PURPLE 16 GAUGE NEEDLES THAN THE PINK 18 GAUGE NEEDLES.
IT WAS REPORTED THAT THE UNSPECIFIED BD 18G NEEDLE EXPERIENCED FOREIGN MATTER ON DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LAB TECHS ARE HAVING ISSUES WITH THE 16 GAUGE AND 18 GAUGE NEEDLES IN THE LAB. THERE SEEMS TO BE EXCESSIVE GLUE HOLDING THE NEEDLE PARTS TOGETHER. THE GLUE IS OCCASIONALLY FLAKING OFF THE NEEDLE AND LANDING IN THE COMPOUNDING AREA. I DON'T HAVE A LOT OF INFO ABOUT LOT AND EXPIRATION. I WAS TOLD IT HAPPENS MORE WITH THE PURPLE 16 GAUGE NEEDLES THAN THE PINK 18 GAUGE NEEDLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834581 | BD PRECISIONGLIDE¿ NEEDLES | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 2245214 | 00382903051960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |