MAUDE Adverse Event Report: JELCO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number	338300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One smiths medical peripheral intravenous catheters (pivc)|jelco safety acuvance catheter was returned for analysis in a used condition.It was also noted that 7 unopened samples and three photos were returned.The first and second photos displayed the catheter assembly with evidence of catheter severance.The third photo displayed the used catheter assembly with detached needle guard assembly and open blister package, as well as an unused catheter assembly, with evidence of catheter severance in the used sample.Unfortunately, the photos taken of the complaint sample did not include a magnified close-up view of the point of detachment.The seven sister samples were visually evaluated and tested for catheter security and were found to be acceptable.The actual sample was examined under magnification and photographed.The eyelet to tube securement area within the catheter hub was intact with no evidence of catheter securement issues.Examination of the catheter assembly noted that the catheter tube was severed at 3/8" above the catheter hub nose, displaying a distinct "v" shape profile of the introducer needle.This "v" shape incision is consistent with a catheter wall penetration by the cannula because of a redirect during deployment and not the result of a manufacturing nonconformance.Examination of the photos of the catheter assembly against smiths medical technical report for investigation into causes of catheter tube separation failure modes suggests the reinsertion of the needle into the catheter severed the catheter tubing.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event was noted to be user interface.
Event or Problem Description
Information was received indicating that a smiths medical peripheral intravenous catheters (pivc)|jelco safety acuvance catheter, was partially sheared off in the baby's hand and was removed at bedside.It was reported that imaging was performed to confirm catheter was fully removed.No further events were reported.

• Brand Name: JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• MDR Report Key: 12476364
• Report Number: 3012307300-2021-09376
• Device Sequence Number: 3892025
• Product Code: FOZ
• UDI-Device Identifier: 10351688071569
• UDI-Public: 10351688071569
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K012128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 06/30/2023
• Device Model Number: 338300
• Device Catalogue Number: 338300
• Device Lot Number: 4005438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2020
• 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: Unknown
• Patient Sequence Number: 1