MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES PICC/ CVC SECURE 20/CS; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Model Number 74564

Device Problem Component Incompatible (1108)

Patient Problem Local Reaction (2035)

Event Date 11/10/2021

Event Type  Injury  

Manufacturer Narrative

The product involved in the report has not been returned and a lot number was not provided.Mai complaint # (b)(4).This is patient 3 of 3 patient had picc line inserted (b)(6) 2021.Rn noted drainage at the insertion site on (b)(6) 2021.Patient was started on bactrim ds.The following week a keloid looking cyst appeared at the insertion site.On (b)(6) 2022, redness and white spots were noted at site.Keflex was started and a different dressing was applied.On (b)(6) 2022, some redness still noted.On (b)(6) 2022, picc line had come out too far to use and was discontinued.(b)(6) suspects the chg dressing component is the source of the skin reaction.Site discontinued use of chg dressing and diverted to an alternate dressing.The patient has improved.3m has been notified and is communicating directly with the patient to further investigate.Medical action industries is the manufacturer of the picc dressing change convenience kit.The complaint component however is a tegaderm dressing with chg, manufactured by 3m.It is vendor item number 1839-2100k.Since there is no complaint lot indicated, the component lot is also unknown.All information reasonably known as of 23feb2022 has been included in this medical device report.Should additional information be obtained, a follow-up medical device report will be provided.(b)(4) has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the (b)(4) complaint database and identified as complaint (b)(4).

Event Description

Mai complaint # (b)(4).This is patient 3 of 3.Patient had picc line inserted (b)(6) 2021.Rn noted drainage at the insertion site on (b)(6) 2021.Patient was started on bactrim ds.The following week a keloid looking cyst appeared at the insertion site.On (b)(6) 2022, redness and white spots were noted at site.Keflex was started and a different dressing was applied.On (b)(6) 2022, some redness still noted.On (b)(6) 2022, picc line had come out too far to use and was discontinued.(b)(6) suspects the chg dressing component is the source of the skin reaction.

Manufacturer Narrative

The product involved in the event report has not been returned and a lot number was not provided by the reporter.Patient number 3 of 3.Medical action industries is the manufacturer of the complaint picc dressing change convenience kit.The complaint component however is a tegaderm dressing with chg, manufactured by 3m.It is vendor item number: 1839-2100k.Since there was no complaint lot specified, the component lot is also unknown.The investigation findings from the supplier 3m indicate this issue was likely not the result of defective product.Per the supplier, the pictures indicated the issue was likely due to improper overall site management.3m determined that the complaints were not considered reportable.3m stated on march 9, 2022, that a 3m application engineering specialist/clinician and a 3m sales rep would contact the reporter and further educate them on best practices for using and maintaining the 3m chg picc/cvc dressing on patients.The complaint is now considered closed.All information reasonably known as of 07apr2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.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 o&m halyard, inc.Product is defective or has caused serious injury.H3 other text: device not returned.

• Brand Name: PICC/ CVC SECURE 20/CS
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): MEDICAL ACTIONS INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005
• MDR Report Key: 13588377
• MDR Text Key: 290691324
• Report Number: 1030451-2022-00003
• Device Sequence Number: 1
• Product Code: PEZ
• UDI-Device Identifier: 20809160020231
• UDI-Public: 20809160020231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

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
• Device Operator: Health Professional
• Device Model Number: 74564
• Device Catalogue Number: 74564
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention