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

Model Number SL28E.

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2019

Event Type  malfunction  

Event Description

Leakage was detected around the hub on both lumens/extensions.When catheter was removed it broke into 2 pieces.

Manufacturer Narrative

The 12.5f hemo-cath was returned for evaluation.Visual inspection of the device revealed holes/leaks in both extensions.Photographs taken under magnification revealed scratches and cuts on both extensions.The cuts appear to have been created with a sharp instrument.The device was forwarded to the contract manufacturer for evaluation.While the device was received at the contract manufacturer location it can no longer be located, so an evaluation of the actual device was not possible.The investigation was conducted based on the photographs taken of the returned device.Damage to the extension lines was confirmed.A review of the manufacture records for the lot reported revealed the device was manufactured according to specification.A definitive root cause cannot be determined.

• Brand Name: 12.5FX28CM HEMO-CATH
• Type of Device: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8906672
• MDR Text Key: 201415838
• Report Number: 2518902-2019-00054
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045994
• UDI-Public: 884908045994
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/11/2021
• Device Model Number: SL28E.
• Device Catalogue Number: SL28E.
• Device Lot Number: MHMP140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR