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

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

Device lot number and udi section of other # is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported via an email notification of a product liability lawsuit that a product failure left part of a peripheral intravenous catheter (pivc) device bilaterally lodged in the patients lungs.On (b)(6) 2019 the patient had an outpatient cardiological nuclear study.Then on (b)(6) 2019 while in route to hospital in ambulance, the needle failure occurred.Emt attempted to insert an iv in the arm during transport, but the attempt failed.Upon removal of iv catheter, it was observed that the catheter not intact.The emt examined the patient for the missing end of the catheter.The emt looked for missing end of catheter, which was not present.Emt noticed a hard knot about the insertion point in the left accessory cephalic (ac) vein.The emt released the tourniquet and removed the catheter.On removal the emt noticed the catheter was not intact.Approximately 3/4 of the catheter was no longer attached and still in patient's arm.Subsequent examination of patient revealed that fragments of the catheter were noted on x-ray and ct to have migrated through the heart and to the pulmonary artery where they are lodged in patient's lungs bilaterally.Additional information was requested; however, no further information was received.

Manufacturer Narrative

The complainant returned two photos for analysis.The photos displayed a device with evidence of catheter shear.Unfortunately, the photos taken of the complaint sample did not include a magnified close-up view of the catheter bevel tip for evidence of mechanical witness marks or manufacturing damage.Given the actual sample was not returned, we were unable to perform an in-depth investigation.Since the lot number is unknown, the review of manufacturing logbook notes and device history could not be conducted.The reported event could not be verified and/or confirmed with confidence, therefore, no further correction, corrective or preventive actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Device history review could not be conducted since the lot number is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: JELCO PROTECTIV SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• 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: 15307365
• MDR Text Key: 298761104
• Report Number: 3012307300-2022-16465
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention