MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-09 for UNSPECIFIED BD? TUBES UNKNOWN manufactured by Becton Dickinson.
[174110041]
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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10
[174110042]
Material no. Unknown batch no. Unknown. It was reported that during use of the unspecified bd? Tubes in a comparative study of urine growth stabilization products after the tube was left at room temperature for 24 hours it demonstrated an increased or of significant growth. The following information was provided by the initial reporter: (bd vacutainer? Urine plus c&s preservative tube): comparison of clinical performance of commercial urine growth stabilization products. Daley p, gill y, midodzi w. Diagnostic microbiology and infectious disease 2018;92:179-182. Urine in us (copan uriswab) and bd at room temperature for 24h demonstrated an increased or of significant growth (us 2. 72, bd 2. 96), although these were (nonsignificantly) higher ors for significant growth compared to refrigeration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-02251 |
| MDR Report Key | 9172368 |
| Date Received | 2019-10-09 |
| Date of Report | 2019-09-27 |
| Date of Event | 2019-09-25 |
| Date Mfgr Received | 2019-09-25 |
| Date Added to Maude | 2019-10-09 |
| 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 | 0 |
| Brand Name | UNSPECIFIED BD? TUBES |
| Generic Name | URINE COLLECTION SYSTEM |
| Product Code | JSM |
| Date Received | 2019-10-09 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | * |
| 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 | 2019-10-09 |