MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for UNSPECIFIED BD? VACUTAINER? URINE COLLECTION TUBE UNKNOWN manufactured by Becton Dickinson.
[139098570]
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. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: as bd life sciences - preanalytical systems had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review. Investigation conclusion: as bd life sciences - preanalytical systems had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review. Root cause description : as there was no sample or photo available for evaluation, 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
[139098571]
It was reported that during use of unspecified bd? Vacutainer? Urine collection tubes, the tubes were under filled. This was not a single event, however the occurrence rate is unknown. (b)(6) also reported that they frequently receive tubes with greater than 8ml or as little as 4ml but believes this is a client dependent issue. It is (b)(6) observation that a urine collection tube filled with less than 7ml is acceptable but wanted to verify with bd as bd has indicated that a sample should be rejected if the tube does not contain 7-8 milliliters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-00323 |
| MDR Report Key | 8368232 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-03-08 |
| Date of Event | 2018-12-26 |
| Date Mfgr Received | 2019-02-04 |
| Date Added to Maude | 2019-02-25 |
| 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? VACUTAINER? URINE COLLECTION TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | KDT |
| Date Received | 2019-02-25 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| 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 | 2019-02-25 |