MAUDE Adverse Event Report: MEDICAL COMPONENTS INC. MEDCOMP J/FLEX GUIDEWIRE

Catalog Number MC35-J

Device Problems Difficult to Insert (1316); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2014

Event Type  malfunction  

Event Description

Resident physician experienced problems with guidewire insertion during bedside cvc placement.Multiple guide wires were used.The bedside nurse reported that initial wire kinked.Additional wire was obtained and subsequently became difficult to remove.Upon inspection when removed, wire appears to have unraveled (like a stretched slinky).Ultimately, line was placed and no patient harm.
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manufacturer response for guidewire for cvc insertion, (brand not provided) (per site reporter).
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replaced device.

• Brand Name: MEDCOMP J/FLEX GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): MEDICAL COMPONENTS INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 3628618
• MDR Text Key: 3987501
• Report Number: 3628618
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: MC35-J
• Device Lot Number: MBLR150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 73 YR