MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-17 for RECONSTITUTION ACCESSORIES 7O5993 manufactured by B. Braun Medical Inc..
[48512426]
(b)(4). Four (4) unused, unopened samples, in packaging indicating the reported lot # 0061385505, were received for evaluation. Upon visual observation, the paper backing of the blister package was noted to be torn/ripped on all four samples. The tears were all near the middle of the package. Due to this issue, the packaging line for this product was inspected and reviewed. The current box size and packaging configuration was validated and found to be sufficient for this product. There have been no changes to the packaging configuration or blister size since. This blister packed product is shipped to a wholesale medical distribution company, where it is packaged into a kit. Since the reported issue was observed at the end user facility, it could not be definitively determined where in the packaging/shipping/handling process this issue occurred. Although our packaging is tested to astm standards during development to ensure that they will maintain integrity under normal to strenuous shipping conditions, excessive handling may result in some damage. Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. If additional pertinent information becomes available a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[48512427]
As reported by the user facility: event # 2: reports two tice bcg units had tubing packaging that had a hole in the plastic, making the tubing unsterile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2016-00370 |
| MDR Report Key | 5733139 |
| Date Received | 2016-06-17 |
| Date of Report | 2015-01-15 |
| Date of Event | 2014-12-29 |
| Date Mfgr Received | 2015-01-15 |
| Device Manufacturer Date | 2014-08-25 |
| Date Added to Maude | 2016-06-17 |
| 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 | MR. ROBERT HUBERT |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RECONSTITUTION ACCESSORIES |
| Generic Name | RECONSTITUTION ACCESSORIES |
| Product Code | FPK |
| Date Received | 2016-06-17 |
| Returned To Mfg | 2015-01-27 |
| Catalog Number | 7O5993 |
| Lot Number | 0061385505 |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-17 |