MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 16F X 32CM SPLIT CATH III

Model Number	DASPC3216-3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mds placing permcath, the catheter snaps/breaks open after placement, but the catheter pieces crumbled into pieces, md checked over all of the pieces, asked for documentation and we placed pieces in container labeled w/pt name and implant sticker.No injury noted to patient.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The complained device was not returned for evaluation.Multiple requests for clarification of the event and additional information were not successful.The contract manufacturer conducted a review of the manufacture records for the lot number provided.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.Without the requested information and an evaluation of the device a root cause cannot be determined.Should the requested information become available at a later date the complaint will be reopened and further investigated.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: 16F X 32CM SPLIT CATH III
• Common Device Name: SPLIT CATH III
• 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: 15615180
• Report Number: 2518902-2022-00060
• Device Sequence Number: 20854704
• Product Code: MSD
• UDI-Device Identifier: 00884908142709
• UDI-Public: 00884908142709
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K040318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 06/08/2024
• Device Model Number: DASPC3216-3
• Device Catalogue Number: DASPC3216-3
• Device Lot Number: MQFL150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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
• Patient Sex: Unknown