MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-11 for BD VACUTAINER? CPT? CELL PREPARATION TUBE WITH SODIUM CITRATE 362761 manufactured by Becton, Dickinson & Co..
[132919922]
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Additionally, 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. Investigation conclusion as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd. Root cause description as there was no sample or photo available for evaluation, a root cause could not be determined. Rationale complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. The bd business team regularly reviews the collected data for identification of emerging trends.
Patient Sequence No: 1, Text Type: N, H10
[132919923]
It was reported that during use of the bd vacutainer? Cpt? Cell preparation tube with sodium citrate the tube was cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-04092 |
| MDR Report Key | 8240461 |
| Date Received | 2019-01-11 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-20 |
| Date Mfgr Received | 2018-12-20 |
| Date Added to Maude | 2019-01-11 |
| 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 | 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? CELL PREPARATION TUBE WITH SODIUM CITRATE |
| Generic Name | LYMPHOCYTE SEPARATION MEDIUM |
| Product Code | JCF |
| Date Received | 2019-01-11 |
| Catalog Number | 362761 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-11 |