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

Model Number 307300

Device Problems Material Puncture/Hole (1504); Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

Unstable infant with perinatal asphyxia required iv access for urgent blood transfusion.(b)(4) 24gx5/8" used to access vein twice and both times it failed.Needle inserted into vein, blood noted in catheter, but sheath would not advance.When pulling out the catheter, the sheath was noted to be punctured in once case and bent in another.Both catheters had to be removed.Medical staff placed central lines to obtain access.Manufacturer response for catheter, intravascular,therapeutic, short-term less than 30 days, (b)(4) (per site reporter).Pending investigation and response, on receipt of the one catheter that was retained and returned to vendor.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 15051655
• MDR Text Key: 296148280
• Report Number: 15051655
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 307300
• Device Lot Number: 4174991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Weight: 3 KG