MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-01 for BD VACUTAINER? K3E 7.2MG PLUS BLOOD COLLECTION TUBES 368860 manufactured by Becton, Dickinson And Company (bd).
[107349555]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation results: summary: bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode for underfill with the incident lot was not observed. Evaluation and testing of the customer samples was performed and underfill was not observed. A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product. Bd has initiated further investigation relating to this issue through a capa. The investigation is still on-going and improvements will be made as the potential causes of this issue are identified. Conclusion: based on evaluation of the customer samples, the customer? S indicated failure mode for underfill with the incident lot was not observed. Further investigation has been initiated through capa 161123. The investigation is still on-going and improvements will be made as the potential causes are identified. Root cause: capa 161123 has been initiated to document further investigation and root cause analysis relating to this issue. The investigation is currently on-going and will be updated as the potential root cause(s) are identified. Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions. The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.
Patient Sequence No: 1, Text Type: N, H10
[107349556]
It was reported that several external producers found underfilling when using bd vacutainer? K3e 7. 2mg plus blood collection tubes. In addition, it was reported the laboratory has found the tubes to be filling slower than other tubes. There was no report of exposure, serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9617032-2018-00103 |
| MDR Report Key | 7477957 |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2017-04-24 |
| Date Added to Maude | 2018-05-01 |
| 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 AND COMPANY (BD) |
| Manufacturer Street | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE |
| Manufacturer City | PLYMOUTH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? K3E 7.2MG PLUS BLOOD COLLECTION TUBES |
| Generic Name | BLOOD COLLECTION TUBE |
| Product Code | PJE |
| Date Received | 2018-05-01 |
| Returned To Mfg | 2018-04-18 |
| Catalog Number | 368860 |
| Lot Number | 7114655 |
| Device Expiration Date | 2018-08-31 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY (BD) |
| Manufacturer Address | BELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-01 |