MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for BD VACUTAINER? URINALYSIS URINE TUBE 364979 manufactured by Becton, Dickinson & Co. (broken Bow).
[139070328]
Date of event: unknown. (b)(6). Investigation summary: bd had not received samples, but photos were provided by your facility for investigation. The photos were evaluated and the indicated failure mode for foreign matter with the incident lot was observed. A review of the manufacturing records was completed for the incident lot and no issues were identified. Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends. Investigation conclusion: based on evaluation of the customer photos, the customer? S indicated failure mode for foreign matter with the incident lot was observed. Root cause description: based on the investigation, a root cause could not be determined. Rationale: complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[139070329]
It was reported that before use of the bd vacutainer? Urinalysis urine tube there was black foreign matter found inside the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-00947 |
| MDR Report Key | 8401256 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2018-06-05 |
| Date Added to Maude | 2019-03-07 |
| 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 & CO. (BROKEN BOW) |
| Manufacturer Street | 150 SOUTH 1ST AVENUE |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? URINALYSIS URINE TUBE |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | KDT |
| Date Received | 2019-03-07 |
| Catalog Number | 364979 |
| Lot Number | 8156641 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-07 |