MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-07 for BIO 701 CONTAINER WITH INSULATION 369656 manufactured by Becton Dickinson.
[94875735]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device lot # unknown; medical device expiration date: unknown; unique identifier (udi) # unknown; device manufacture date: unknown. Results: a sample was not returned for evaluation. The defect could not be confirmed from the photo. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode.
Patient Sequence No: 1, Text Type: N, H10
[94875736]
It was reported that bio 701 container with insulation had locks that wouldn't close correctly, they see to get loose and the container can not be closed. No injury or medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2017-00309 |
| MDR Report Key | 7095536 |
| Date Received | 2017-12-07 |
| Date of Report | 2017-11-08 |
| Date of Event | 2015-12-10 |
| Date Mfgr Received | 2015-12-10 |
| Date Added to Maude | 2017-12-07 |
| 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 |
| 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIO 701 CONTAINER WITH INSULATION |
| Generic Name | TERTIARY BOX |
| Product Code | KER |
| Date Received | 2017-12-07 |
| Catalog Number | 369656 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| 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 | 2017-12-07 |