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

Model Number	338300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information was received.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.One (1) photo was returned.The photo displayed a used device with evidence of catheter shear.Unfortunately, the photo taken of the complaint sample did not include magnified closed up views of the cannula and catheter bevel tips for evidence of mechanical witness marks or manufacturing damage or of the body and hook components for excess adhesive or manufacturing damage.The reported issue could not be confirmed as no product sample was received for evaluation.Root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
Event or Problem Description
It was reported that the catheter sheared during insertion.No patient injury was reported.

• Brand Name: JELCO SAFETY ACUVANCE CATHETERS
• 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): 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: 15397527
• Report Number: 3012307300-2022-18482
• Device Sequence Number: 5057239
• Product Code: FOZ
• UDI-Device Identifier: 10351688071569
• UDI-Public: 10351688071569
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/10/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2023
• Device Model Number: 338300
• Device Catalogue Number: 338300
• Device Lot Number: 4095292
• Was Device Available for Evaluation?: No
• 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: 04/28/2022
• Initial Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown