MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-13 for IV CVR INVISION PLUS * RYM5001 manufactured by Rymed.
[5780980]
Rn went to assess pt. When she followed her iv line down to give pain medication, she realized propofol tubing was lying on the ground with the iv cap broken off inside the luer lock. Experiencing problems with rymed ((b)(4)) connectors. They are breaking off in the tubing and nurses are finding the broken tubing when they assess the pts. There were 5 instances of this in (b)(6), with lot numbers ro1857 and ro1839. All of the connectors that were broken in those lots were shipped to (b)(6) for testing. The process takes a little over a week. Their qa dept found nothing wrong with the connectors. In the interim, lot number ro1860 was delivered at the first of (b)(6). Since then, three reportable instances of connectors breaking have occurred. Two of those three broken connectors will also be sent to (b)(6) for testing (the other was not available). Our facility has carried the rymed connectors for roughly four years and until now, has never seen a rush of instances like these. The rymed sales rep was contacted and we are told the connectors needed to be changed every 24 hours, which was unclear to out facility until then. We are working on a process to put this action into place. See mw5042740-mw5042743 and mw5042746.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042744 |
| MDR Report Key | 4778592 |
| Date Received | 2015-05-13 |
| Date of Report | 2015-05-13 |
| Date of Event | 2015-05-09 |
| Date Added to Maude | 2015-05-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV CVR INVISION PLUS |
| Generic Name | CONNECTOR |
| Product Code | FPA |
| Date Received | 2015-05-13 |
| Model Number | * |
| Catalog Number | RYM5001 |
| Lot Number | RO1857 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RYMED |
| Manufacturer Address | * FRANKLIN TN 37064 US 37064 |
| Brand Name | IV CVR INVISION PLUS |
| Generic Name | CONNECTOR |
| Product Code | DTN |
| Date Received | 2015-05-13 |
| Catalog Number | RYM5001 |
| Lot Number | RO1839 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | RYMED |
| Manufacturer Address | FRANKLIN TN 37064 US 37064 |
| Brand Name | IV CVR INVISION PLUS |
| Generic Name | CONNECTOR |
| Product Code | DTN |
| Date Received | 2015-05-13 |
| Catalog Number | RYM5001 |
| Lot Number | RO1860 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | RYMED |
| Manufacturer Address | FRANKLIN TN 37064 US 37064 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-13 |