MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for BD VACUTAINER? GLASS CPT MOLECULAR DIAGNOSTICS TUBE 362753 manufactured by Becton, Dickinson & Co..
[126580146]
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.
Patient Sequence No: 1, Text Type: N, H10
[126580147]
It was reported that a bd vacutainer? Glass cpt molecular diagnostics tube broke right after turning on the centrifuge. There was no report of exposure, serious injury, or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-03719 |
| MDR Report Key | 8048107 |
| Date Received | 2018-11-07 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-18 |
| Date Added to Maude | 2018-11-07 |
| 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? GLASS CPT MOLECULAR DIAGNOSTICS TUBE |
| Generic Name | LYMPHOCYTE SEPARATION MEDIUM |
| Product Code | JCF |
| Date Received | 2018-11-07 |
| Catalog Number | 362753 |
| 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 | 2018-11-07 |