MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-17 for BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE 364915 manufactured by Becton, Dickinson And Company (bd).
[186303508]
Medical device expiration date: unknown. 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
[186303509]
It was reported that bd vacutainer? Z (no additive) plus urine tube contained foreign matter. The following information was provided by the initial reporter: "plastic flakes when tubes go through tempus. Customer has a tempus pneumatic tube system for sending tubes 1 by 1 on air pressure since 2017. Since 1 year they noticed particulates being shed at the fan of the system. The fan is above the ceiling so the particulates would collect themselves on the ceiling. (see pictures for situation and particulates). Suspicion is that the particulates is plastic from the tubes. The customer has asked the supplier of the transport system first but also got us involved now. Hypothesis, since the homogeneity of the particulates, that it might be the big 16x100 urine tube they use, so this complaint is filed on that product number but not sure it is this product and not able to pinpoint a lot number since a lot tubes are involved / sent over the pneumatic system over the years. We're looking with the customers for more investigations. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2020-00255 |
| MDR Report Key | 9845081 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-17 |
| 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 | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? Z (NO ADDITIVE) PLUS URINE TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | JSL |
| Date Received | 2020-03-17 |
| Catalog Number | 364915 |
| 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 AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |