| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | I.V. START KIT | I.V. KIT | MEDICAL ACTION INDUSTRIES, INC. | LRS | 72424 | 72424 | 177909 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-03-07 | 0 |
Patient 1
(B)(4). PRODUCT PROBLEM: TEGADERM DRESSING IN IV KIT HAS PORTION FOLDED ONTO ITSELF, WHICH MAKES IT DIFFICULT TO USE ON THE PATIENT. A SEPARATE DRESSING FROM STOCK WAS OBTAINED. DEFECTIVE TEGADERM DRESSING WAS NOT USED; NO INJURY TO PATIENT.
Patient 1
ON (B)(6) 2014, MEDICAL ACTION INDUSTRIES ("MAI") RECEIVED MEDWATCH (B)(4), THAT HAD BEEN FILED WITH FDA BY (B)(6) THE MEDWATCH WAS FOR AN ISSUE WITH A TEGADERM DRESSING. MAI DOES NOT MANUFACTURE THE TEGADERM DRESSING ITSELF BUT MANUFACTURES THE IV START KIT THAT CONTAINED THE DRESSING. THE TEGADERM WAS MANUFACTURED BY 3M CORPORATION, ITEM (B)(4), LOT 201507KA. MAI OPENED COMPLAINT (B)(4) FOR THIS ISSUE AND BEGAN A COMPLETE INVESTIGATION. INVENTORY OF THE COMPLAINT LOT HAD BEEN EXHAUSTED; HOWEVER, MAI PERFORMED INSPECTION OF INVENTORY OF OTHER LOTS AND 100% OF TEGADERM SAMPLES PASSED SPECIFICATIONS. MAI RECEIVED THE DEFECTIVE SAMPLE FROM (B)(6)ON (B)(6) 2014 AND WAS ABLE TO CONFIRM THE DEFECT: THE TEGADERM HAD AN UNIDENTIFIED PIECE OF WHIT PLASTIC IN BETWEEN THE RELEASE PAPER AND THE STICKY PART OF THE TEGADERM. THIS APPEARS TO BE A MANUFACTURING ERROR. THIS IS THE FIRST COMPLAINT OF THIS NATURE FOR THIS TEGADERM AND THIS STYLE KIT; THE COMPLAINT WAS DETERMINED TO BE AN ISOLATED INCIDENT. MAI SENT SCAR (B)(4) (SUPPLIER CORRECTIVE ACTION REQUEST) TO 3M TO DETERMINE ROOT CAUSE AND CORRECTIVE/PREVENTIVE ACTIONS. ALL RESPONSIBLE PARTIES FOR THIS PRODUCT LINE WERE NOTIFIED OF THIS COMPLAINT FOR AWARENESS. MAI WILL CONTINUE TO TRACK AND TREND ISSUE.