MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915 manufactured by Becton, Dickinson And Company (bd).
[146513195]
(b)(6). Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation. The photos were evaluated and the customer's indicated failure mode for overfill with the incident lot was not observed as the tube appeared to be empty. Additionally, retention samples were selected from bd inventory for testing and upon completion, no issues were observed relating to draw volume as all samples met specifications. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product. Investigation conclusion: based on evaluation of the retention samples and photos, the customer? S indicated failure mode for overfill with the incident lot was not observed as all samples met the required specifications. Additionally, the photos did not identify a specific product issue. Root cause description: based on the investigation, a root cause could not be determined. The retain product was found to be in conformance and meet release specifications.
Patient Sequence No: 1, Text Type: N, H10
[146513196]
It was reported that overfill occurred with a bd vacutainer? Z (no additive) plus urine tube. The following information was provided by the initial reporter, "urine tube 11 ml fills too much and on the track of roche device the urine leak from the tube after opening of the tube. " 200 occurrences were reported, but the date/time and patient information is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2019-00600 |
| MDR Report Key | 8617467 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-29 |
| Date Mfgr Received | 2019-04-30 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2019-05-16 |
| 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 AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | JSL |
| Date Received | 2019-05-16 |
| Catalog Number | 364915 |
| Lot Number | 9063852 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-16 |