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

Model Number	305506
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/23/2021
Type of Reportable Event	Serious Injury
Event or Problem 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 emergency room "deportment" md.

• Brand Name: JELCO
• Common Device Name: CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 12147783
• Report Number: 3012307300-2021-07105
• Device Sequence Number: 4215881
• Product Code: FOZ
• UDI-Device Identifier: 10351688071095
• UDI-Public: 10351688071095
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 67