MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for BD VACUTAINER? CPT? MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE 362760 manufactured by Becton, Dickinson & Co..
[91206191]
Date of event: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. Results: a sample or photo is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. 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
[91206192]
It was reported that a bd vacutainer? Cpt? Mononuclear cell preparation tube - sodium citrate?? (13x100? Mm? /? 4ml) tubes were breaking during centrifugation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2017-00263 |
| MDR Report Key | 6984221 |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-06 |
| Date of Event | 2016-08-26 |
| Date Mfgr Received | 2016-08-26 |
| Date Added to Maude | 2017-10-27 |
| 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? MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE |
| Generic Name | SPECIMEN COLLECTION TUBE |
| Product Code | JCF |
| Date Received | 2017-10-27 |
| 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 | 2017-10-27 |