MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number 306301

Device Problem Defective Device (2588)

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

Event Date 03/20/2022

Event Type  malfunction  

Event Description

It was reported that there were nine attempts to place an iv.The initial attempt and second attempt did not result in blood return.The cat scan department had no issues getting a vein but the iv safety catheters would not disconnect and the entire iv would come out in one piece.This occurred four times.Additional attempts were made on a bed sheet to see if the iv catheter could disconnect and it would not.After eight attempts of starting an iv site the patient was started.After the patient's scan was started the iv site stopped working 37 minutes into the test.The site was inserted with an ultrasound and a new box of catheters.

Manufacturer Narrative

Other, other text: three units were returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated.Packaging lot 4068767 was produced on pcm3 on 15, 16oct20 ((b)(4)).Nonconformance data identified one in-process nonconformance, however, the nonconforming product was from totes not included in lot 4068767 and was scrapped 100 percent.Based on analysis of unused samples, the complaint cannot be confirmed as a manufacturing nonconformance.

Manufacturer Narrative

Corrected data: b1, corrected data: corrected data: b1-product problem.

• Brand Name: JELCO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14137083
• MDR Text Key: 289455280
• Report Number: 3012307300-2022-06531
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071224
• UDI-Public: 10351688071224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2023
• Device Model Number: 306301
• Device Catalogue Number: 306301
• Device Lot Number: 4068767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0789-2017
• Patient Sequence Number: 1