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

Model Number	328500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One catheter assembly, with detached, locked out needle guard assembly and without sheath component and blister packaging, was returned for analysis.The sample was visually examined for potential related nonconformance.Examination of the catheter assembly displayed the seal fully actuated with no evidence of catheter severance, catheter bevel tip irregularities, cracked catheter hub, catheter hub luer damage, actuator-to-tube securement issues or mechanical witness marks.Examination of the needle guard assembly displayed normal flash in the flashback chamber with no evidence of bent or broken cannula, cannula bevel tip irregularities, damage to nose component, or locking mechanism damage noted.Additionally, the sample was evaluated for luer lock per stm550 using an (iso figure 7-gauge) and was found to be acceptable.Review of manufacturing logbooks identified no definitive causal factor for the issue.Based on device analysis, the complaint cannot be confirmed as a manufacturing nonconformance.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Smiths medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Event or Problem Description
It was reported that after starting the iv the reporter was unable to hookup the iv line due to part of the plastic catheter breaking off inside the green cannula that was inserted into the patients vein.The entire green cannula was promptly removed from the patients arm and then the patient needed another iv start.There was no patient injury reported.

• Brand Name: JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13455873
• Report Number: 3012307300-2022-02583
• Device Sequence Number: 12311734
• Product Code: FOZ
• UDI-Device Identifier: 10351688081933
• UDI-Public: 10351688081933
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/04/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2023
• Device Model Number: 328500
• Device Lot Number: 4121844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown