MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-03 for BDVACUTAINER? CPT? 362780 manufactured by Becton, Dickinson & Co..
[116212846]
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: 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 glass breakage 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. Investigation conclusion: based on evaluation of the customer photos, the customer? S indicated failure mode for glass breakage with the incident lot was observed. Root cause description: based on the investigation, a root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[116212847]
It was reported that a bdvacutainer? Cpt? Had broke when the customer attempted to removed the tube from the vacutainer. It was removed when the customer noticed it was failing to fill as well as the other tubes. There was report of exposure to the blood, but no medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-03148 |
| MDR Report Key | 7749553 |
| Date Received | 2018-08-03 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-07-10 |
| Date Mfgr Received | 2018-07-12 |
| Date Added to Maude | 2018-08-03 |
| 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 | BDVACUTAINER? CPT? |
| Generic Name | BLOOD COLLECTION TUBE |
| Product Code | JCF |
| Date Received | 2018-08-03 |
| Catalog Number | 362780 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-03 |