MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 14F X 32CM SPLIT CATH III; SPLIT CATH III HEMODIALYSIS CATHETER

Model Number	ASPC32-3
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information from the facility stated "we don't feel that the catheter was at fault, but we have to ask these questions to complete our review." the device involved in the incident was not returned for evaluation.Additional information was requested and not provided.Without sufficient information, or an evaluation of the device involved, we are unable to determine the cause or factors that may have contributed to this event and if the failure could have been related to the manufacturing process.It is possible the connection was not fully secured at the initiation of the treatment.The female luers on the catheter are manufactured to meet the iso standard.They are universal female luers and will mate with any universal male luer of the bloodlines, syringes, injection caps, etc.If they are also manufactured to the iso standard.It is possible that there was a deficiency with the gambro cartridge blood tubing set.
Event or Problem Description
During dialysis, "the tubing connection became unsecure from the lumen of dialysis catheter".

• Brand Name: 14F X 32CM SPLIT CATH III
• Common Device Name: SPLIT CATH III HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9415469
• Report Number: 2518902-2019-00074
• Device Sequence Number: 1724800
• Product Code: MSD
• UDI-Device Identifier: 00884908003857
• UDI-Public: 884908003857
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: ASPC32-3
• Device Catalogue Number: ASPC32-3
• Device Lot Number: MLHV830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/05/2019
• 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