MAUDE Adverse Event Report: MEDCOMP 14F X 28CM PC SPLIT CATH III

Model Number ASPC28-3PCE.

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint and returned sample were forwarded to the contract device manufacturer for evaluation.

Event Description

The patient took out the catheter inserted the day before.The suture wing and the suture were still attached to the patient's skin, the suture was not ripped off.The catheter separated from the suture wing.

Manufacturer Narrative

Based on the investigation performed and the results of the pull-test inspection, a root cause could not be attributable to manufacture process.We are unable to determine the exact cause of the event; however, it appears that at some point enough force was applied to the catheter to dislodge it from the suture wing.

• Brand Name: 14F X 28CM PC SPLIT CATH III
• Type of Device: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7682727
• MDR Text Key: 114047210
• Report Number: 2518902-2018-00043
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908003758
• UDI-Public: 884908003758
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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: Other
• Device Expiration Date: 09/09/2021
• Device Model Number: ASPC28-3PCE.
• Device Catalogue Number: ASPC28-3PCE.
• Device Lot Number: MHTV770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90