MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO VIAVALVE SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number 326610

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/03/2022

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Seven (7) product sample photos were received for evaluation.Visual inspection found four of the photos (photos #2, 3 (duplicate files) and 4) displayed the blister top stock for one of the affected lots reported by customer.The remaining three photos (photos # 1, 5 and 6) displayed evidence of normal to excessive amounts of flashback in the flash chambers and blood pooling inside the guard and nose components as noted by customer.Given the photos were not a magnified view of the needle guard assemblies and photos of the valved catheter assemblies were not included, it was not possible to determine any potential causal factor for the reported seal leakage.Further, given no product has been provided we could not confirm whether a quality related issue has resulted in the customer reported problem.No functional testing could be performed as no samples were received.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that after iv initiated and before plastic needle housing is removed from the catheter hub, blood fills the chamber and then spills out of needle housing.No patient injury was reported.

• Brand Name: JELCO VIAVALVE SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15210930
• MDR Text Key: 302574025
• Report Number: 3012307300-2022-15234
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078428
• UDI-Public: 15019517078428
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: 326610
• Device Catalogue Number: 326610
• Device Lot Number: 4272555
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1