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

Model Number	SL18P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a dressing changed the catheter was noted to be twisted and no sutures were present in either of the hub holes.The line was untwisted and a dressing and extra tape was applied to keep the line flat.Later the patient was out of bed.A family member lifted the patient up and there was a slight tug on the line.The staff was notified that the line "came apart".
Additional Manufacturer Narrative
The 8f x 18cm hemo-cath was received for evaluation and was forwarded to the device contract manufacturer for investigation.A full review of hemo-caths manufacturing processes was done.Nothing out of specification was found.The issue is considered not related to the manufacturing process.It appears the catheter lumen may have been stressed beyond the design capabilities.

• Brand Name: 8F X 18CM HEMO-CATH
• Common Device Name: HEMO-CATH LT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8214295
• Report Number: 2518902-2019-00001
• Device Sequence Number: 19339299
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K893439
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019
• Report Date (Section F): 12/04/2018

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: 03/19/2023
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MKBN640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: 2 YR
• Patient Weight: 13