MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-04 for BD VACUTAINER? CPT? MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE. 362760 manufactured by Becton, Dickinson & Co..
[94105120]
Medical device expiration date: unknown. Device manufacture date: unknown. Results: 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 poor serum/plasma with the incident lot was observed. However, bd was unable to determine the specific lot number associated with this complaint. Therefore, a review of the device history record could not be conducted. Conclusion: without a sample, an absolute root cause for this incident cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[94105121]
It was reported that a couple of the bd vacutainer? Cpt? Mononuclear cell preparation tube had unexpected presentation of blood draws after centrifugation. No serious injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00521 |
| MDR Report Key | 7080709 |
| Date Received | 2017-12-04 |
| Date of Report | 2017-11-14 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-09-13 |
| Date Added to Maude | 2017-12-04 |
| 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? MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE. |
| Generic Name | BLOOD COLLECTION TUBE. |
| Product Code | JCF |
| Date Received | 2017-12-04 |
| Catalog Number | 362760 |
| Lot Number | UNKNOWN |
| 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 | 2017-12-04 |