MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 11F X 90CM DBL LMN CVC; LT SILICONE CVC

Model Number	MR28011121
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of returned device is ongoing, no conclusions can be drawn.A follow up report will be submitted when the investigation is complete.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
The cvc was being flushed.The catheter had vancomycin instilled and 2mls was withdrawn.When 10mls of ns was flushed the catheter broke and saline squirted out.Applied a hemostat to the catheter line to prevent further leaks.The patient required catheter replacement.User facility submitted medwatch (b)(4) for this event.
Additional Manufacturer Narrative
Received one 11f double lumen silicone cvc catheter for evaluation.The lumen was trimmed ~27cm distal to the hub.A visual examination indicated that the luers, extensions, clamps and hub are intact with no visible defects or abnormalities.Suture material is wrapped tightly around the lumen ~ 3.5cm proximal to the cuff.When flushed the lumens leak at a tear located just below the hub.There is also a tear in the lumen just proximal to the cuff.The device was implanted for 5 months with no reported issues.The suture material is tightly wound around the lumen and may have contributed to the lumen rupture, particularly if flushed against resistance over time.The root cause of this issue cannot be determined but is most likely not manufacture related.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: 11F X 90CM DBL LMN CVC
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10051217
• Report Number: 2518902-2020-00022
• Device Sequence Number: 3357718
• Product Code: LJS
• UDI-Device Identifier: 00884908084306
• UDI-Public: 884908084306
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K003110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 05/15/2024
• Device Model Number: MR28011121
• Device Catalogue Number: MR28011121
• Device Lot Number: MNKT570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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