MAUDE Adverse Event Report: MEDCOMP 16F X 24CM SPLIT CATH III; HEMODIALYSIS CATHETER

Model Number	ASPC2416-3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 16f x 24cm split cath iii was returned for evaluation.The device is in two pieces.The lumen is detached 1cm from the hub.The edges of the break are smooth.The device was forwarded to the contract manufacturer for evaluation.
Event or Problem Description
The device was implanted with no complications and during suturing the catheter broke in half.
Additional Manufacturer Narrative
The investigation of the complaint included a review of the device history record (dhr), a review of the returned sample, and the manufacturing process.The review indicated there were no non-conformances or authorized manufacturing variances issued for the lot involved.Dhr review found that the lots involved in the manufacture of the reported part number was manufactured within specifications per customer requirements.There was no visible damage to the luers, sleeves, extensions, clamps, or hub.The lumen was completely torn approximately 0.4" distal to the hub-to-lumen junction.The lumen also was stretched near the area of the tear.A cross section of the lumen taken near the tear met specifications.Root cause: based on the investigation performed a root cause could not be attributed to the manufacturing processes.The reported lot was manufactured according to established procedures and specifications.

• Brand Name: 16F X 24CM SPLIT CATH III
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7494502
• Report Number: 2518902-2018-00031
• Device Sequence Number: 13536632
• Product Code: MSD
• UDI-Device Identifier: 00884908003604
• UDI-Public: 884908003604
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

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: 04/01/2020
• Device Model Number: ASPC2416-3
• Device Catalogue Number: ASPC2416-3
• Device Lot Number: MJNC830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 10/08/2018
• 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