MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-07-31 for INTERLINK LEVER LOCK CANNULA 303370 manufactured by Bd.
[3622762]
The reporter stated that the lever lock was connected for the infusion through a central venous line. The user felt something wrong and checked the dripping condition. There was no drip observed, the user removed the lever lock. Then, the user found lever lock cannula abnormality. Lever lock cannula seemed to be broken. The central venous catheter was discontinued due to the possibility of a broken piece remaining inside the body. In search for the broken portion of cannula, a ct scan was taken and central venous catheter was cut in half, a flow was searched but no broken piece was found.
Patient Sequence No: 1, Text Type: D, B5
[10914909]
One piece was received and the short cannula was confirmed based on the sample evaluation. A dhr review was conducted and there were no issues found during the packaging of the batch. This damage is manufacturing related and a corrective action project has been implemented to address occurrences of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243072-2013-00089 |
| MDR Report Key | 3264176 |
| Report Source | 01,07 |
| Date Received | 2013-07-31 |
| Date of Report | 2013-07-30 |
| Date of Event | 2013-06-30 |
| Date Mfgr Received | 2013-07-01 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-08-06 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH CLOSNER, RN, BSN |
| Manufacturer Street | 1 BECTON DR. |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2105265165 |
| Manufacturer G1 | BD |
| Manufacturer Street | ROUTE 7 & GRACE WAYECTON |
| Manufacturer City | CANAAN CT 06018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERLINK LEVER LOCK CANNULA |
| Generic Name | LOCKING CANNULA FOR IV CONNECTION |
| Product Code | FGY |
| Date Received | 2013-07-31 |
| Returned To Mfg | 2013-07-08 |
| Catalog Number | 303370 |
| Lot Number | 2296200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Manufacturer Address | 1 BECTON DR. FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-31 |