1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE
Report
- Report Number
- 1213809-2021-00809
- Event Type
- Malfunction
- Date Received
- December 9, 2021
- Date of Event
- October 22, 2021
- Report Date
- December 14, 2021
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903095972
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: 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. 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.
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 THE 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE EXPERIENCED A NEEDLE CLOG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACEUTICALS COMPANY RECEIVED A COMMERCIAL PRODUCT COMPLAINT RELATING TO ANCILLARY COMPONENTS FOR USE WITH GATTEX. WAS THERE ANY ADVERSE EVENTS DUE TO THE REPORTED ISSUE? MEDICAL INTERVENTION? COURSE OF TREATMENT CHANGE? OTHER ACTIONS? -N/A.
IT WAS REPORTED THAT THE 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE EXPERIENCED A NEEDLE CLOG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACEUTICALS COMPANY RECEIVED A COMMERCIAL PRODUCT COMPLAINT RELATING TO ANCILLARY COMPONENTS FOR USE WITH GATTEX. ¿WAS THERE ANY ADVERSE EVENTS DUE TO THE REPORTED ISSUE? MEDICAL INTERVENTION? COURSE OF TREATMENT CHANGE? OTHER ACTIONS? -N/A.
IT WAS REPORTED THAT THE 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE EXPERIENCED A NEEDLE CLOG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACEUTICALS COMPANY RECEIVED A COMMERCIAL PRODUCT COMPLAINT RELATING TO ANCILLARY COMPONENTS FOR USE WITH GATTEX. WAS THERE ANY ADVERSE EVENTS DUE TO THE REPORTED ISSUE? MEDICAL INTERVENTION? COURSE OF TREATMENT CHANGE? OTHER ACTIONS? -N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1870999 | 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309597 | 0080940 | 30382903095972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |