MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-18 for BD LUER-LOK? TIP SYRINGE 309653 manufactured by Bd Medical (bd West) Medical Surgical.
[186325607]
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9207664, medical device expiration date: 2024-07-31, device manufacture date: 2019-07-26. Medical device lot #: 8303508, medical device expiration date: 2023-10-31, device manufacture date: 2018-10-30. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186325608]
It was reported that 1 bd luer-lok? Tip syringe from lot# 9207664, and 12 syringes from lot# 8303508, were found before use with incorrect label information. The following information was provided by the initial reporter: "warehouse has the following of 309653 that were purchased from you that are labeled wrong. Original po# lot# qty 4510748405 9207664 1 4510002971 8303508 12"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00269 |
| MDR Report Key | 9850654 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-18 |
| 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 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD LUER-LOK? TIP SYRINGE |
| Generic Name | PISTON SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-18 |
| Model Number | 309653 |
| Catalog Number | 309653 |
| Lot Number | SEE SECTION H.10. |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |