MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH HEMODIALYSIS CATHETER

Model Number	SL18P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received a 8f lt hemo-cath for evaluation.A visual inspection revealed the catheter to be in two pieces.The break is located under the cuff, which is still intact.The device was forwarded to the device contract manufacturer for evaluation.
Event or Problem Description
Pt.Was admitted for shock.Line was determined to be in need of removal.At bedside removal was attempted, "the catheter snapped" and surgical evaluation was obtained.Pt.Was taken to the or for removal of retained portion of catheter.
Additional Manufacturer Narrative
Based on the investigation performed, the catheter met all required specifications.All process and procedure were reviewed and found to be adequate.The catheter was implanted for 6 weeks and shows no signs of degradation.The described failure mode cannot be assigned to any of the internal manufacturing processes.External factors could have contributed to the reported failure mode during the removal of the catheter.

• Brand Name: 8F X 18CM HEMO-CATH
• Common Device Name: HEMO-CATH HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6639970
• Report Number: 2518902-2017-00026
• Device Sequence Number: 19077921
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

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: 03/31/2021
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MCBH930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 09/12/2017
• 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: 2 YR
• Patient Weight: 15