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

Model Number 305706

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Manufacturer Narrative

Three used and four unused smiths medical peripheral intravenous catheters (pivc)|jelco safety protectiv catheters were returned for analysis.The used samples were visually examined for potential nonconformances.The locked-out needle guard assemblies displayed normal flash in the flashback chamber with no evidence of bent or broken cannula.After the device was reassembled and gently returned to unlocked position, magnified examination of the device tip displayed no evidence of cannula tip irregularities or catheter bevel high trim.All three used catheter assemblies displayed evidence of bevel tip damage indicating premature advancement of the catheter during use.Magnified examination of the catheter tubes noted punctures at approximately mid-tube length in two of the three catheter assemblies, displaying the "j" shape profile of the introducer needle.This "j" shape incision is consistent with a catheter wall penetration by the cannula as a result of a redirect during insertion and not the result of a manufacturing nonconformance.The four unused, unopened sister samples were visually evaluated for potential nonconformances and tested for force to advance and force to lock.The unused sister samples were found to be acceptable.Examination of the photos of the used catheter assemblies against smiths medical technical report for investigation into causes of catheter shear failure modes suggests the reinsertion of the needle into the catheter sheared/punctured the catheter tubing.Based on device analysis, the reported event was determined to be due to a variation in insertion technique.Based on the evidence, the complaint was not confirmed, and the problem source of the reported event was noted to be user interface.

Event Description

Information was received indicating that a smiths medical peripheral intravenous catheters (pivc)|jelco safety protectiv catheter, broke/bent upon insertion.No patient consequences were reported.No adverse effects were reported.

• Brand Name: JELCO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 12481043
• MDR Text Key: 271682516
• Report Number: 3012307300-2021-09406
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071149
• UDI-Public: 10351688071149
• Combination Product (y/n): N
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: 305706
• Device Catalogue Number: 305706
• Device Lot Number: 4062864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1