MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for BLOOD COLLECTION DEVICE W/MALE LUER MBC6010 manufactured by Becton Dickinson.
[137559193]
The manufacturing location for this product is (b)(4). This site is an oem manufacturing site. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Investigation summary: bd had not received samples or photos from the customer facility for investigation; therefore, the investigation was limited. Retention samples of the incident lot were selected from bd inventory for evaluation and mechanical testing; upon completion, all results met release specifications. 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 conducted further investigation relating to this issue through a capa where improvement opportunities have been identified and are in the process of being implemented. Investigation conclusion: based on the evaluation of the retain samples, all results met release specifications. However, further investigation activities have been conducted through a capa where improvement opportunities have been identified. As a result, these improvements are being implemented to help reduce further occurrences. Root cause description: a capa was conducted to document further investigation and root cause analysis relating to this issue. The investigation has identified improvement opportunities in the manufacturing process and as a result, these improvements are being implemented to help reduce further occurrences. 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. The investigation has identified improvement opportunities in the manufacturing process and as a result, these improvements are being implemented to help reduce further occurrences.
Patient Sequence No: 1, Text Type: N, H10
[137559194]
It was reported that a blood collection device w/male luer is breaking off in the needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2019-00186 |
| MDR Report Key | 8318532 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2018-06-29 |
| Date Added to Maude | 2019-02-07 |
| 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 | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | PAS-19-1355-FA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLOOD COLLECTION DEVICE W/MALE LUER |
| Generic Name | COLLECTION DEVICE |
| Product Code | KST |
| Date Received | 2019-02-07 |
| Catalog Number | MBC6010 |
| Lot Number | 18052501 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |