MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5FX60CM SGL PRO PICC CT-LONGGW; PRO-PICC CT

Model Number	MR17035102
Medical Device Problem Codes	Entrapment of Device (1212); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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.
Event or Problem Description
Guidewire coiled/knotted when advanced to auxiliary vein.Difficult to remove wire, would not unravel.
Additional Manufacturer Narrative
The device involved in the incident was returned for evaluation.It was reported that the device tip had knotted.Visual inspection of the returned device revealed no signs of knotting.The guidewire is kinked approximately 3.5 cm from the tip.The ball tip and core wire are intact.It appears the guidewire may have been stressed beyond the design capabilities.The guidewire contract manufacturer was notified of the incident and conducted a review of the manufacture records for the lot number reported.The method used for the investigation was device history record (dhr) review which determined the following: personnel was properly trained; no reports of internal nonconformance were found; the reviews of the dhr demonstrate compliance and conformance to applicable procedures and specifications.Based on the event description provided, there is no evidence to confirm the issue was caused by inadequate manufacture of the product.The root cause is indeterminable.

• Brand Name: 5FX60CM SGL PRO PICC CT-LONGGW
• Common Device Name: PRO-PICC CT
• 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: 14454605
• Report Number: 2518902-2022-00036
• Device Sequence Number: 20437725
• Product Code: LJS
• UDI-Device Identifier: 00884908033175
• UDI-Public: 884908033175
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2022

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/01/2025
• Device Model Number: MR17035102
• Device Catalogue Number: MR17035102
• Device Lot Number: MQDB570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 60 KG