MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6F X 60 CM TPL VLVD CT PICC BASIC; PRO-PICC CT W/VALVE

Model Number	MR82036301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Breakage of the bi-directional valve on the yellow tract which separated into two pieces during post-sampling irrigation with 10 ml syringe of 0.9% nacl.
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The devices involved were not returned for evaluation.One photograph was provided showing the yellow valve luer is in two separate pieces.It appears that the luer cap separated from the rest of the luer.Medcomp engineering reviewed the photograph.They determined the juncture should be incredibly strong as the cap is welded to the base using an ultrasonic welding process.As a result, a supplier corrective action request was issued to the contract manufacturer for this event.The contract manufacturer conducted a review of the manufacture records for the lot number provided.In addition, two kits from the same lot were returned for evaluation and forwarded to the contract manufacturer.Their investigation revealed the root cause was failure to properly follow the procedure when setting up the welder for the process that welds the cap to the housing.This caused an improper gap created between the horn and the valve holding fixture.As a result, the contract manufacturer will update the procedures to include adjustment of the gap.The gap distance will also be included in the record of the process and will be verified by the inspector.All personnel involved in the procedures will be trained to the updates.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6F X 60 CM TPL VLVD CT PICC BASIC
• Common Device Name: PRO-PICC CT W/VALVE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16093719
• Report Number: 2518902-2023-00002
• Device Sequence Number: 6516378
• Product Code: LJS
• UDI-Device Identifier: 00884908101812
• UDI-Public: 00884908101812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/01/2025
• Device Model Number: MR82036301
• Device Catalogue Number: MR82036301
• Device Lot Number: MQHG570
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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: Required Intervention
• Patient Sex: Unknown