MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F X 18CM HEMO-CATH; HEMO-CATH LT

Model Number	SL18P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient was implanted with the 8f hemo-cath in (b)(6) 2019.In (b)(6) 2020 a leak was noted just below the hub.Fluoroscopy detected a leak in the lumen.The catheter was exchanged.In the days prior to the event, the sutures had become loose.Medical staff examined the device after explant and stated the leak appears to be a hole and not a rupture.
Additional Manufacturer Narrative
Received one 8f hemo-cath for evaluation.The lumen is cut 2.5 inches distal to the cuff.A functional examination revealed a hole in the blue lumen just below the hub and a hole in the red lumen just above the cuff.Both leak when the device is flushed and appear to be pin holes.The device was implanted for 7 months with no reported issues.The pin holes appear to have been caused by a sharp object and is most likely not manufacture related.A definitive root cause cannot be determined.The instructions for use (ifu) includes the following catheter precautions: do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 8F X 18CM HEMO-CATH
• Common Device Name: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9990624
• Report Number: 2518902-2020-00020
• Device Sequence Number: 11681542
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K893439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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: 01/31/2020
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MBYV560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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: 1 YR
• Patient Weight: 10