MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-03-19 for SYRINGE 3ML LS 24X1 AN BAWAL 307754 manufactured by Becton Dickinson.
[186286483]
Medical device expiration date: unknown. (b)(6). Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186286484]
It was reported that syringe 3ml ls 24x1 an bawal contained foreign matter. The following information was provided by the initial reporter: "dr found some liquid / sticky material inside barrel after pulling plunger of new syringe after unpacking. After interacting with customer i came to know that he had destroyed those faulty syringes afterwards. On asking other details of product doctor replied he will let me know if finds same kind of problem in next lot of syringes. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00452 |
| MDR Report Key | 9856975 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYRINGE 3ML LS 24X1 AN BAWAL |
| Generic Name | SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Catalog Number | 307754 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |