MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES IV START KIT

Model Number	74654
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Mai complaint number (b)(4).Incident five.The hub is not properly attaching to the 7" ext.Tubing.This occurred while connecting to patient line resulting in some patient blood loss.
Additional Manufacturer Narrative
The product involved in the report was not available for return.Incident 5 of 5.Medical action industries is the manufacturer of the iv start kit convenience kit.The complaint component extension set, part number mc33122-ns is manufactured by icu medical (fda registration 9615050).A supplier corrective action (scar) was submitted to the manufacturer on 23may2023.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.

• Brand Name: IV START KIT
• Common Device Name: IV START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; asheville NC 28704
• Manufacturer (Section G): MEDICAL ACTION INDUSTRIES; 25 heywood road; asheville NC 28704
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17050387
• Report Number: 1047429-2023-00005
• Device Sequence Number: 17014152
• Product Code: LRS
• UDI-Device Identifier: 10809160020388
• UDI-Public: 10809160020388
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 74654
• Device Catalogue Number: 74654
• Device Lot Number: 305500
• 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: 05/04/2023
• Initial Report FDA Received Date: 06/02/2023
• 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