MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-14 for MEDICAL ACTION INDUSTRIES 68909 manufactured by Medical Action Industries.
[69898969]
A review of the history of change requests for central line dressing kits, 68909, confirms there have been no component changes made to the kit since original manufacturing initiated in 2006. At the time of complaint receipt, mai did not have any inventory of the complaint product or component lot available for further inspection. A three year complaint history for the kit and other kits containing this same dressing (lot), shows no other complaints received of similar nature associated with report of patient reaction. There have additionally been no internal non-conformances for this component within the past three years. The device history record for the kit production lot was reviewed; all in-process inspections were conducted and found to be conforming. The tegaderm component was documented to have been picked for the work order from the correct warehouse location for this component. A history review of the warehouse location confirms no other similar dressings were placed in the same location which would attribute to an incorrect component. The root cause for this patient reaction; therefore, remains unknown but isolated in nature. Medical action industries (mai) has logged the complaint into our trending database where we will continue to monitor for any subsequent complaints or trends for this issue. 3m has been notified of the reported occurrence.
Patient Sequence No: 1, Text Type: N, H10
[69898970]
Office manager called in complaint to customer service inquiring as to whether something had changed with dressing contained in the central line dressing kit, 68909, manufactured by medical action industries. A patient had a reaction to the dressing component. On 02/16/2017, more details were received from the physician regarding this occurrence. The patient had been receiving weekly infusions since (b)(6) 2017 with no prior reactions. On (b)(6) 2017, the patient started having adverse effects including blistering (rash) around the dressing area. The office has tried several different supplies to treat the skin irritation, but the patient is still experiencing issues. The physician treated the patient symptoms and the picc line was removed. Medical action industries (mai) manufactures convenience kit item 68909, central line dressing kit; however, 3m is the manufacturer of the complaint component tegaderm dressing. The component is vendor part number 1655ns (lot: 202109xo) and is a transparent tegaderm polyurethane film coated with hypoallergenic adhesive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2017-00002 |
| MDR Report Key | 6402881 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-14 |
| Date of Report | 2017-03-13 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2016-12-22 |
| Date Added to Maude | 2017-03-14 |
| 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 | NICHOLE EARLY |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8283387567 |
| Manufacturer G1 | 3M COMPANY |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | CENTRAL LINE DRESSING KIT |
| Product Code | PEZ |
| Date Received | 2017-03-14 |
| Model Number | 68909 |
| Catalog Number | 68909 |
| Lot Number | 228943 |
| Device Expiration Date | 2018-08-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC 28701 US 28701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-14 |