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

Model Number	306301
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Other text: corrected data: b1 and h1, corrected data: corrected data: b1-product problem and h1-type of reportable event: malfuction.

• Brand Name: JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• 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: 14137119
• Report Number: 3012307300-2022-06538
• Device Sequence Number: 12323665
• Product Code: FOZ
• UDI-Device Identifier: 10351688071224
• UDI-Public: 10351688071224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/22/2022; 06/14/2023
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/18/2022; 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0789-2017
• Patient Sequence Number: 1
• Patient Sex: Unknown