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 2020-02-17 for BD VACUTAINER? Z (NO ADDITIVE) URINE TUBE 364938 manufactured by Becton, Dickinson & Co. (broken Bow).
[188047296]
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9004601. Medical device expiration date: 2021-01-31. Device manufacture date: 2019-01-04. Medical device lot #: 8215601. Medical device expiration date: 2020-08-31. Device manufacture date: 2018-08-03. Medical device lot #: 8011855. Medical device expiration date: 2020-01-31. Device manufacture date: 2018-01-11. Medical device lot #: 9036662. Medical device expiration date: 2021-02-28. Device manufacture date: 2020-01-31. Medical device lot #: 8215601. Medical device expiration date: 2020-08-31. Device manufacture date: 2021-02-28. Medical device lot #: 9004601. Medical device expiration date: 2021-01-31. Device manufacture date: 2019-01-04. Medical device lot #: 8215601. Medical device expiration date: 2020-08-31. Device manufacture date: 2021-01-31. Medical device lot #: 8011855. Medical device expiration date: 2020-01-31. Device manufacture date: 2018-01-11. Medical device lot #: 9036662. Medical device expiration date: 2021-02-28. Device manufacture date: 2019-02-05. Medical device lot #: 8215601. Medical device expiration date: 2020-08-31. Device manufacture date: 2018-08-03. Medical device lot #: 9004601. Medical device expiration date: 2021-01-31. Device manufacture date: 2019-01-04. Medical device lot #: 8215601. Medical device expiration date: 2020-08-31. Device manufacture date: 2018-08-03. Medical device lot #: 8011855. Medical device expiration date: 2020-01-31. Device manufacture date: 2018-01-11. Medical device lot #: 9036662. Medical device expiration date: 2021-02-28. Device manufacture date: 2019-02-05. Medical device lot #: 8215601. Medical device expiration date: 2020-08-31. Device manufacture date: 2018-08-03. Medical device lot #: 8215601. Medical device expiration date: 2020-08-31. Device manufacture date: 2018-08-03.
Patient Sequence No: 1, Text Type: N, H10
[188047297]
It was reported before use the bd vacutainer? Z (no additive) urine tube there was no label or missing label information ( all packaging levels), foreign matter in tube; biological and non-biological, broken lid/cap, tubes/ extenders with molding defects (non-cosmetic) that can be used. The following information was provided by the initial reporter:? The costumer complained about few deficiencies: absence of barcode sticker. The tube interior is dirty. The rubber head is dirty, torn and damaged. The tube is conail and not round bottom as it should be?.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00138 |
| MDR Report Key | 9717812 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-17 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-26 |
| Date Mfgr Received | 2020-01-26 |
| Date Added to Maude | 2020-02-17 |
| 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 & 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 | 3 |
| Brand Name | BD VACUTAINER? Z (NO ADDITIVE) URINE TUBE |
| Generic Name | TRANSPORT CULTURE MEDIUM |
| Product Code | JSL |
| Date Received | 2020-02-17 |
| Catalog Number | 364938 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| 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 | 2020-02-17 |