MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX28CM HEMO-CATH; HEMO-CATH LT

Model Number	SL28
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the return of the device for evaluation.
Event or Problem Description
The arterial and venous luers at the end of the extension lines became loose, with the venous luer completely disconnecting from the extension line.Alcohol prep pads are used to cleanse the lines, using a total of about 8-10 prep pads during the connection and disconnection process.More pads are used if the patient's line has to be reversed at any point during treatment.
Additional Manufacturer Narrative
After visual inspection of the returned device, a review of the manufacture records for the lot, and the fact that the device was implanted for approximately 4 months without any reported issue, it was determined that the root cause of this issue is not manufacturing based.A definitive root cause cannot be determined.

• Brand Name: 12.5FX28CM HEMO-CATH
• Common Device Name: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8859297
• Report Number: 2518902-2019-00047
• Device Sequence Number: 16272051
• Product Code: MSD
• UDI-Device Identifier: 00884908045864
• UDI-Public: 884908045864
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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?: Yes
• Operator of Device: Other
• Device Model Number: SL28
• Device Catalogue Number: SL28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: 16 YR