MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC JELCO SAFETY VIAVALVE CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number SR-FVP2225P

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2019

Event Type  malfunction  

Event Description

It was reported that immediately after inserting the catheter into the patient, and after advancing it into the blood vessel, the operator felt some resistance.The operator also experienced some initial difficulty with removing the cap from the product.

Manufacturer Narrative

Twenty seven unopened catheters were returned for evaluation.Further investigation of these returned samples found them to be acceptable.Three devices, including one used locked out needle guard assembly with detached catheter assembly and without sheath, were returned for evaluation.Initial examination of the used locked out needle guard assembly and detached catheter assembly indicated that dried blood was present on the inside of the guard component and the outside of the catheter hub.Examination of the introducer did not reveal any damage or other issue.The catheter hub and seal also did not show any evidence of any issue.Retraction and advancement of the introducer guard also did not reveal any difficulty in movement.Additionally, the remaining two samples were visually examined for any potential related nonconformances and found to be acceptable.The samples were manually inverted and the devices advanced freely and smoothly without hesitation.Devices were manually advanced, they clicked, and locked out as designed, showing no evidence of having been locked out.Blood on the inside of the introducer guard indicates interruption or hesitancy in guard advancement, which allows blood to flow out of the flash-vue cannula window while the window is briefly uncovered during guard advancement.Oon the outside of the catheter hub, the blood observed may also indicate that there was a delay in connection between the catheter hub and the extension set or other device used.It should be noted that during use, the valve is not intended to prevent backflow of blood in the guard.The reported customer complaint has not been confirmed.The root cause of blood pooling is due to variation in insertion technique and not the result of a manufacturing non-conformance.

• Brand Name: JELCO SAFETY VIAVALVE CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8777178
• MDR Text Key: 150594969
• Report Number: 3012307300-2019-03768
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/30/2020
• Device Catalogue Number: SR-FVP2225P
• Device Lot Number: 3623610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1