MAUDE Adverse Event Report: MEDCOMP 11.5FX15CM HEMO-CATH; HEMO-CATH ST

Model Number SLD11/15

Device Problem Disconnection (1171)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to medcomp for evaluation.An investigation request was sent to device contract manufacturer.

Event Description

While rolling the patient the catheter accidently came out without any force.Suture port remained in situ, however the line slipped through the port and came out.No harm to the patient was reported.

• Brand Name: 11.5FX15CM HEMO-CATH
• Type of Device: HEMO-CATH ST
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 8247658
• MDR Text Key: 134375954
• Report Number: 2518902-2019-00007
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00541376500528
• UDI-Public: 541376500528
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/08/2020
• Device Model Number: SLD11/15
• Device Catalogue Number: SLD11/15
• Device Lot Number: MBYY570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention