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

Catalog Number 335603

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation in progress.

Event Description

It was reported that after inserting the catheter into the vein, it would not allow the operator to thread.It was also very hard to get detachment from the jelco slide.A catheter from a different lot number was subsequently used on the patient.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

Two unopened and unused jelco safety acuvance plus catheters samples were returned for analysis.The samples were visually examined finding no discrepancies.A force to advance test was performed and was found to be acceptable.Based on the evidence the reported event could not be confirmed.Therefore, no root cause can be drawn.

• Brand Name: JELCO SAFETY ACUVANCE PLUS 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
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7939489
• MDR Text Key: 122865887
• Report Number: 3012307300-2018-03881
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/23/2021
• Device Catalogue Number: 335603
• Device Lot Number: 3584515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1