MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-20 for MEDICAL ACTION INDUSTRIES 73775 manufactured by Medical Action Industries Inc..
[36948954]
Medical action industries (mai) received a hospital complaint of tegederm with 2% chg within kit 73755 on (b)(6) 2015. Mai did not have any remaining stock of complaint lot 213403 to evaluate at that time. The device history record for work order 213403 did not indicate any non-conformances during production of the associated lot. Subsequent work orders of this same kit, 73755, were inspected. The correct tegederm dressing was found to be produced in current inventory lots. The raw material for this component was evaluated and the correct tegederm dressings without chg were found for the item; therefore, no other product lots appear to be affected. The work order 213403 was produced in october 2015 and included (b)(4) cases of product which was shipped to four different customers. Mai's initial investigation indicates that the error occurred during the work order picking process; however, this investigation is still in progress for additional root cause analysis and corrective/preventive action plan.
Patient Sequence No: 1, Text Type: N, H10
[36948955]
On (b)(6) 2015, (b)(6) reported to medical action industries (mai) that they had found two tegederm dressings with 2% chg on patients inside kits manufactured by mai. The kits purchased from medical action industries were ref:73775, kit: picc/cvc secure dres chg 20/c, lot: 213403. This kit should have contained a tegederm dressing without chg gel. These two patients had no adverse reaction associated with the chg dressing use. The hospital confirmed no other patient reactions associated with this kit use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2016-00002 |
| MDR Report Key | 5379281 |
| Date Received | 2016-01-20 |
| Date of Report | 2016-01-19 |
| Date of Event | 2015-12-21 |
| Date Mfgr Received | 2015-12-21 |
| Device Manufacturer Date | 2015-10-14 |
| Date Added to Maude | 2016-01-20 |
| 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 | 8283387568 |
| Manufacturer G1 | MEDICAL ACTION INDUSTRIES INC |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | PICC/CVC SECURE DRESSING CHANGE KIT |
| Product Code | PEZ |
| Date Received | 2016-01-20 |
| Returned To Mfg | 2016-01-16 |
| Model Number | 73775 |
| Catalog Number | 73775 |
| Lot Number | 213403 |
| Device Expiration Date | 2017-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES INC. |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-20 |