SYRINGE ENTERAL 10ML BNS
Report
- Report Number
- 1213809-2019-00492
- Event Type
- Malfunction
- Date Received
- May 1, 2019
- Date of Event
- April 11, 2019
- Report Date
- June 21, 2019
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903058587
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: TWO PHOTOS AND ONE LOOSE 10ML ORAL SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A SMALL ORANGE PIECE OF FOREIGN MATTER IN THE FLUID PATH WEDGED IN THE TIP OF THE SYRINGE. IT APPEARS TO BE A PIECE OF PLASTIC FROM A TIP CAP. FTIR (FOURIER TRANSFORM INFRARED ) SPECTROSCOPY ANALYSIS WAS COMPLETED ON THE ORANGE MATERIAL OBSERVED IN THE TIP OF THE SYRINGE AND WAS COMPARED WITH THE FTIR ANALYSIS OF THE LOOSE ORANGE TIP CAP RECEIVED ALONG WITH THE SYRINGE. A SMALL PORTION OF EACH OF THESE MATERIAL WAS REMOVED AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THE MATERIAL IN THE TIP OF THE SYRINGE IS MOST LIKELY POLYPROPYLENE WHILE THE MATERIAL OF THE TIP CAP IS MOST LIKELY POLYETHYLENE. 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. TIP CAPS ARE NOT MANUFACTURED OR PACKAGED WITH THIS PRODUCT. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED.
IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE ENTERAL 10ML BNS THE SYRINGE IS BLOCKED DUE TO A FOREIGN OBJECT. MATERIAL NO.: 305858 BATCH NO.: UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER EMAIL: PLEASE BE ADVISED THAT WE HAVE RECEIVED THE ABOVE NOTED COMPLAINT CONCERNING THE 10ML FOR ORAL/ENTERAL USE ONLY SYRINGE COMPONENT WHERE THE CUSTOMER ADVISED THAT THE TIP OF THE SYRINGE WAS FOUND TO BE COMPLETELY BLOCKED.
IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE ENTERAL 10ML BNS THE SYRINGE IS BLOCKED DUE TO A FOREIGN OBJECT. MATERIAL NO.: 305858 BATCH NO.: UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER EMAIL: PLEASE BE ADVISED THAT WE HAVE RECEIVED THE ABOVE NOTED COMPLAINT CONCERNING THE 10ML FOR ORAL/ENTERAL USE ONLY SYRINGE COMPONENT WHERE THE CUSTOMER ADVISED THAT THE TIP OF THE SYRINGE WAS FOUND TO BE COMPLETELY BLOCKED.
DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8283661; MEDICAL DEVICE EXPIRATION DATE: 2023-09-30; DEVICE MANUFACTURE DATE: 2018-10-10; MEDICAL DEVICE LOT #: 7249730; MEDICAL DEVICE EXPIRATION DATE: 2022-08-31; DEVICE MANUFACTURE DATE: 2017-09-06; MEDICAL DEVICE LOT #: 7312795; MEDICAL DEVICE EXPIRATION DATE: 2022-10-31; DEVICE MANUFACTURE DATE: 2017-11-08; MEDICAL DEVICE LOT #: 8108771; MEDICAL DEVICE EXPIRATION DATE: 2023-03-31; DEVICE MANUFACTURE DATE: 2018-04-18; MEDICAL DEVICE LOT #: 8120914; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2018-04-30. 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 BEFORE USE OF THE SYRINGE ENTERAL 10ML BNS THE SYRINGE IS BLOCKED DUE TO A FOREIGN OBJECT. MATERIAL NO.: 305858, BATCH NO.: UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER EMAIL: PLEASE BE ADVISED THAT WE HAVE RECEIVED THE ABOVE NOTED COMPLAINT CONCERNING THE 10ML FOR ORAL/ENTERAL USE ONLY SYRINGE COMPONENT WHERE THE CUSTOMER ADVISED THAT THE TIP OF THE SYRINGE WAS FOUND TO BE COMPLETELY BLOCKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361314 | SYRINGE ENTERAL 10ML BNS | ENTRAL SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | SEE H.10 | 00382903058587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |