MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-09-07 for MEDICAL ACTION INDUSTRIES 75648 manufactured by Medical Action Industries.
[54099775]
Medical action industries received the above stated complaint from university hospitals of (b)(6) on (b)(6) 2016. At the time of complaint receipt, medical action industries opened internal complaint (b)(4). Medical action industries confirmed with the hospital that the sorbaview dressing, (b)(4), manufactured by (b)(4) which was included and chosen during initial kit production was an adhesive free center dressing. Medical action industries confirmed the dressing included within the complaint kit was the correct dressing which met product specifications for the device. This dressing was approved for picc line dressing application. Medical action industries produced 3 product lots using the dressing. This hospital complaint was the first received for this issue. The new products team worked with the customer to select a different sorbaview dressing which has the adhesive center for more securement protection. The sterile dressing version of this new dressing was shipped to the customer directly from centurion for usage with the kit in the interim. A supplier corrective action request was issued to (b)(4) on 08/16/2016 for corrective/preventive action plan for this component. They are currently investigating this complaint as related to their component with a projected completion day of 30 days.
Patient Sequence No: 1, Text Type: N, H10
[54099776]
University hospitals of (b)(6) reported that the sorbaview securement dressing contained within medical action industries' picc dressing change convenience kit, 75648, did not appropriately secure patient's picc line. The patient therefore had to be admitted to hospital because the homecare division did not have anyone on friday afternoon to place a new patient line. The patient had to have new line placement with medications due to missed medication dose. There was no known long term adverse affects as a result of this instance. The sorbaview dressing, item: (b)(4), is manufactured by (b)(4). This component is purchased by medical action industries as an approved component for this convenience kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2016-00012 |
| MDR Report Key | 5933404 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-09-07 |
| Date of Report | 2016-08-29 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2016-08-08 |
| Device Manufacturer Date | 2016-06-13 |
| Date Added to Maude | 2016-09-07 |
| 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 | MEDICAL ACTION INDUSTRIES |
| 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 | 3 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | CENTRAL VENOUS CATHETER DRESSING CHANGE KIT |
| Product Code | PEZ |
| Date Received | 2016-09-07 |
| Model Number | 75648 |
| Catalog Number | 75648 |
| Lot Number | 221978 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| 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 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-09-07 |