MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-21 for 16X125MM 8.0 ML BD VACUTAINER? GLASS CPT MOLECULAR DIAGNOSTICS TUBE 362761 manufactured by Becton, Dickinson & Co..
[80898817]
Results: a sample is not available for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6085686. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode. Not confirmed. Three retention lot samples were evaluated during this clinical investigation. All three retention and control lot samples performed as expected and no product issues were observed during the clinical investigation. This is the first complaint reported with regards this lot number. Bd was unable to duplicate or confirm the customer? S indicated failure (glass breakage during centrifugation) mode because the defect was not evident in the testing of the customer samples. This incident and lot number will be monitored for future occurrences. This complaint is not confirmed with regards to breakage during centrifugation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[80898818]
I was reported that 16 x 125 mm 8. 0 ml bd vacutainer? Glass cpt molecular diagnostics tube were breaking during centrifugation. No injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00042 |
| MDR Report Key | 6734494 |
| Date Received | 2017-07-21 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-01-27 |
| Date Mfgr Received | 2017-01-27 |
| Device Manufacturer Date | 2016-03-25 |
| Date Added to Maude | 2017-07-21 |
| 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 |
| 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 | 8015652845 |
| 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 | 16X125MM 8.0 ML BD VACUTAINER? GLASS CPT MOLECULAR DIAGNOSTICS TUBE |
| Generic Name | BLOOD COLLECTION TUBE |
| Product Code | FKA |
| Date Received | 2017-07-21 |
| Catalog Number | 362761 |
| Lot Number | 6085686 |
| Device Expiration Date | 2017-04-30 |
| Device Availability | N |
| 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 | 2017-07-21 |