MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-27 for BD VACUTAINER? CPT GLASS MOLECULAR DIAGNOSTICS TUBE 362753 manufactured by Becton, Dickinson & Co..
[93611299]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Result: bd had not received samples, but photos were provided by the customer facility for investigation. The photos were evaluated and the customer's indicated failure mode for breakage with the incident lot was observed. A review of the manufacturing records was completed for the incident lot # 5105880 and no issues were identified. 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.
Patient Sequence No: 1, Text Type: N, H10
[93611300]
It was reported that 16x125 mm. , 8. 0 ml. Bd vacutainer? Cpt glass molecular diagnostics tube. Green/red conventional closure. See thru label. Additive: density gradient polymer gel and sodium heparin for mononuclear cell preparation, broke during centrifugation. No injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00355 |
| MDR Report Key | 7058841 |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-08 |
| Date of Event | 2016-02-21 |
| Date Mfgr Received | 2016-02-21 |
| Device Manufacturer Date | 2015-04-15 |
| Date Added to Maude | 2017-11-27 |
| 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 | BD VACUTAINER? CPT GLASS MOLECULAR DIAGNOSTICS TUBE |
| Generic Name | CELL PREP TUBE |
| Product Code | JCF |
| Date Received | 2017-11-27 |
| Catalog Number | 362753 |
| Lot Number | 5105880 |
| 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 | 2017-11-27 |