MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES PICC CLEAR SEQUENCE KIT

Model Number	81208
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report was not available for return.Incident 1 of 2: medical action industries is the manufacturer of the picc clear sequence kit.The complaint component tegaderm, part number 1657ns is manufactured by 3m (fda registration (b)(4)).A supplier corrective action (scar) was submitted to the manufacturer on 31may2023.A follow-up report will be provided upon conclusion of investigation and response by the manufacturer.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or caused serious injury.H3 other text : device not returned.
Event or Problem Description
Mai complaint #: (b)(4).Patient one: patients in the icu were experiencing redness, blistering, irritation, itchy burning sensation around the tegaderm adhesive.A patient with a dialysis catheter (ij) had a picc dressing kit that was used on (b)(6).A blistering/skin tear was noticed on (b)(6) 2023 and the patient received wound care treatment on (b)(6) 2023.The patient is allergic to aleve, naproxen and tuberculin skin test.
Additional Manufacturer Narrative
The product involved in the report was not available for return.Incident 1 of 2.We issued a supplier corrective action request (scar) 200041838 to 3m to further address the issue and to respond with their investigation results.3m conducted a thorough investigation and is monitoring trends for additional occurrences.As a part of the investigation, complaint history and manufacturing history were reviewed.No nonconforming materials or defective parts were identified from the investigation.There is no evidence to suggest that there is a product quality issue.The root cause is likely repeated dressing changes over an extended period of time, patient sensitivity to dressing adhesive materials, patient sensitivity to chg, clinician not allowing skin prep to dry completely before applying the dressing or applying the dressing to an actively bleeding site.Blistering can occur when too much tension is applied to the dressing during product application.Itching can be caused by inappropriate and/or repeated application and subsequent removal of dressing from skin in short amount of time.Please refer to product ifu for warnings, precautions, site prep, application, removal, and site care instructions.Medical action industries has documented this complaint for tracking and trending purposes.This information is submitted pursuant to 21cfr803,, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or caused serious injury.This product incident is documented in the complaint database and identified as complaint (b)(4).

• Brand Name: PICC CLEAR SEQUENCE KIT
• Common Device Name: PICC CLEAR SEQUENCE KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17076253
• Report Number: 1030451-2023-00006
• Device Sequence Number: 6243915
• Product Code: OWL
• UDI-Device Identifier: 10809160341797
• UDI-Public: 10809160341797
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 81208
• Device Catalogue Number: 81208
• Device Lot Number: 304464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown