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

Model Number	SL28
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
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 available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Exit suture due for removal from medcomp central line.Suture wrapped tightly around line, used a suture removal kit.After suture removal patient became anxious, short of breath, with chest discomfort.Dr.Came and assessed placed immediately on oxygen and placed on her right side.We were able to determine that there was air in lumen of central line, later found a small hole in line near exit site.Line promptly removed by md.Pt kept for 2 hours post line removal and was discharged from clinic stable.Placed on oxygen and placed on right side central line immediately removed.Once line removed symptoms resolved.
Additional Manufacturer Narrative
The silicone hemo-cath was returned for evaluation.Visual inspection confirms the complaint as a leak of the lumen is noted approximately 3.5 cm from the hub.Approximately 0.3 cm distal to the leak the lumen is scratched and scuffed.It was determined this was caused by a suture that was tightly wrapped around the lumen.The suture wing on the catheter was not used to secure the device to the patient's skin as per the instructions for use.Under magnification it can be seen that the hole is smooth, indicative of being cut with a sharp instrument.The patient reaction is reported to have begun immediately after suture removal.It is possible the lumen was accidentally cut during suture removal.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any gaps such holes, tears or non-bonded unions that could lead to an assembly detachment or malfunction.A definitive root cause cannot be determined but is not likely manufacture related.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12.5FX28CM HEMO-CATH
• Common Device Name: HEMO-CATH LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 14084335
• Report Number: 2518902-2022-00026
• Device Sequence Number: 5288730
• Product Code: MSD
• UDI-Device Identifier: 00884908045864
• UDI-Public: 884908045864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 02/06/2024
• Device Model Number: SL28
• Device Catalogue Number: SL28
• Device Lot Number: MPSJ210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown