MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for BD VACUTAINER? URINALYSIS CONCIAL URINE TUBE NO ADDITIVE 364980 manufactured by Becton, Dickinson & Co..
[136855686]
(b)(6). Investigation summary: no customer samples were received to be evaluated. 3 photos were received. The 3 customer photos were inspected with no issues being identified. The device history records were reviewed with no issues being identified. There were no related quality notifications. All process and final inspections comply with specification requirements. Investigation conclusion: upon evaluation of the customer returned photos, the customer? S product issue was not observed during visual inspection of the tube. This product does not contain additive per specification, no condensation was seen in the tube. The device history records were reviewed with no issues being identified. There were no related quality notifications. All process and final inspections comply with specification requirements. Root cause description: based on the investigation, no product issue was identified as the product was found to be in conformance and meet release specifications. Rationale: bd was unable to confirm the customer? S indicated failure mode with the photos provided. Bd life sciences? Preanalytical systems received no samples and 3 photos from the customer facility for investigation. Based on the visual inspection/evaluation of the samples, bd pas did not observe? Fm? On the product. The device history records were reviewed with no issues being identified. There were no related quality notifications. All process and final inspections comply with specification requirements.
Patient Sequence No: 1, Text Type: N, H10
[136855687]
It was reported that two of the bd vacutainer? Urinalysis concial urine tubes no additive experienced foreign matter contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-00233 |
| MDR Report Key | 8336831 |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2018-07-06 |
| Date Added to Maude | 2019-02-13 |
| 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. |
| 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 CONCIAL URINE TUBE NO ADDITIVE |
| Generic Name | SPECIMEN TRANSPORT AND STORAGE CONTAINER |
| Product Code | NNK |
| Date Received | 2019-02-13 |
| Catalog Number | 364980 |
| Lot Number | 8187644 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-13 |