MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-27 for TRIPLE-LUMEN 7FR. POLYURETHANE CVC KIT * AK-15703 manufactured by Arrow International, Inc.
[1263767]
Staff noted that there is no filter needle included in this kit, although the medication included in the kit is in an ampule. All lots from this product are affected--this is not a case of a filter needle missing from one kit: it is not included in the kit at all. All clinical references indicate that a medication drawn from an ampule should be drawn up with a filter needle. When interviewing nursing staff and physicians who use this kit routinely, all indicated that "everything needed is in the kit. " it is not their practice to pull a sterile filter needle or use one when using the kit, although all said that if they were drawing up from an ampule, a filter needle should be used. Members of the healthcare team recommend the manufacturer consider one of the following:1. Change the medication in the kit from an ampule to a multi-dose vial. 2. Include a filter needle in the kit as a standard piece of equipment if a multi-dose vial is not an option. 3. Reference current literature and/or research findings regarding drawing up medications from an ampule without a filter needle. This kit contains one 5ml ampule of 1% lidocaine solution. A copy of this report has been faxed to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1466658 |
| MDR Report Key | 1466658 |
| Date Received | 2009-08-27 |
| Date of Report | 2009-08-27 |
| Date of Event | 2009-08-27 |
| Report Date | 2009-08-27 |
| Date Reported to FDA | 2009-08-27 |
| Date Added to Maude | 2009-09-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIPLE-LUMEN 7FR. POLYURETHANE CVC KIT |
| Generic Name | KIT, CENTRAL CATHETER, NEEDLE |
| Product Code | OFF |
| Date Received | 2009-08-27 |
| Model Number | * |
| Catalog Number | AK-15703 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL, INC |
| Manufacturer Address | A SUBSIDIARY OF TELEFLEX, INC. 2400 BERNVILLE ROAD READING PA 19605 US 19605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-27 |