MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10FX15CM SILICONE SGL LMN CATH; SILICONE SINGLE LUMEN

Model Number	SSL1015ME.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the sample to be returned for evaluation.
Event or Problem Description
Catheter was perforated.At the beginning of the dialysis session the nurse noted air in the line causing dialysis to stop immediately.A new catheter was inserted.The catheter was clamped after removing the guidwire and was connected to a "y" connector because it was a single lumen catheter.Air was noted in the extension.The perforation was noted between the extension and the hub.
Additional Manufacturer Narrative
Evaluation of the device revealed a small puncture that can only be seen when stretching the tubing.A review of the manufacture records showed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process included a leak test of 100% of these devices.This test would have identified the puncture if it had occurred during the manufacture process.Based on the evaluation of the device, the review of the manufacture records, and the fact that the device was implanted for two days prior to detection of the puncture, it was determined that the root cause is most likely not manufacture related.The instructions for use (ifu) contain the following catheter precaution: do not use sharp instruments near the extension lines or tubing.Do not use scissors to remove dressing, as this could possibly cut or damage catheter.Do not suture through any part of the catheter.Catheter tubing can tear when subjected to excessive force or rough edges.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: 10FX15CM SILICONE SGL LMN CATH
• Common Device Name: SILICONE SINGLE LUMEN
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9284390
• Report Number: 2518902-2019-00069
• Device Sequence Number: 1935175
• Product Code: MSD
• UDI-Device Identifier: 00884908049497
• UDI-Public: 884908049497
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K800741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 09/02/2022
• Device Model Number: SSL1015ME.
• Device Catalogue Number: SSL1015ME.
• Device Lot Number: MJKJ060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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: 72 YR
• Patient Weight: 78