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

Model Number	ASPC28-3PCE.
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint and returned sample were forwarded to the contract device manufacturer for evaluation.
Event or Problem 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.
Additional 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
• Common Device Name: SPLIT CATH III
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7682727
• Report Number: 2518902-2018-00043
• Device Sequence Number: 1398302
• Product Code: MSD
• UDI-Device Identifier: 00884908003758
• UDI-Public: 884908003758
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90