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

Model Number 305506

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Distress (2329); Foreign Body In Patient (2687)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

Event Description

It was reported per medwatch (b)(4): upon assessment of piv, it was noted that catheter was missing.Site assessed and felt as if catheter was still in patients arm.Ultrasound confirmed iv catheter retention.A clinical decision made noting the benefit of removing the foreign body did not outweigh the risk.

Manufacturer Narrative

Other, other text: device history review could not be conducted given that the lot number was unknown.

• 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: 14875672
• MDR Text Key: 295049572
• Report Number: 3012307300-2022-12739
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071095
• UDI-Public: 10351688071095
• 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
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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
• Device Model Number: 305506
• Device Catalogue Number: 305506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 10/20/2022
• 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): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 59 KG