MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13.5F X 24CM SILICONE CATHETER; HEMO-CATH ST

Model Number ECS1324

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.Currently waiting for the sample to be returned for evaluation.

Event Description

Intensive care staff noted air in the catheter and discontinued use.Catheter was replaced with another from the same lot number.Icu manager and attending clinician are uncertain if the hole was there prior to use or if a clinician accidentally punctured the catheter while suturing it to the patient.

Manufacturer Narrative

The catheter was returned for evaluation.Visual inspection revealed a small slit approximately 0.5cm from the hub.Medcomp engineering reviewed the returned device and determined the cause of the hole is indeterminate, possible cause is a needle puncture.The device is 100% leak tested during the production process, which would have identified the hole at the time of manufacture.The cause of the issue is most likely not manufacture related.Definitive root cause cannot be determined.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: 13.5F X 24CM SILICONE CATHETER
• Type of Device: HEMO-CATH ST
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9687567
• MDR Text Key: 198870794
• Report Number: 2518902-2020-00005
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00541376500527
• UDI-Public: 541376500527
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/04/2020
• Device Model Number: ECS1324
• Device Catalogue Number: ECS1324
• Device Lot Number: MBYY530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention