MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO; CATHETER

Model Number 305506

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2021

Event Type  Injury  

Event Description

Information received a smiths medical peripheral intravenous catheters (pivc)|jelco safety protectiv catheters broke off during iv attempt.Iv had to be surgically removed from patients arm by er deportment md.

• Brand Name: JELCO
• Type of Device: CATHETER
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12147717
• MDR Text Key: 260948715
• Report Number: 3012307300-2021-07103
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/26/2024
• Device Model Number: 305506
• Device Catalogue Number: 305506
• Device Lot Number: 4104043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 67