MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. JELCO® PROTECTIV® SAFETY I.V. CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 305606

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/16/2019

Event Type  Injury  

Event Description

Information was received indicating that upon removing a smiths medical jelco® protectiv® safety i.V.Catheter from the patient's left arm, the catheter was observed to be not attached.Subsequently, the patient had the 3cm piece of catheter surgically removed.There were no further adverse effects.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA,; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis,, MN 55442 ; 7633833310
• MDR Report Key: 9076023
• MDR Text Key: 158810808
• Report Number: 3012307300-2019-05008
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071101
• UDI-Public: 10351688071101
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2022
• Device Catalogue Number: 305606
• Device Lot Number: 3804643
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2019
• 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
• Patient Outcome(s): Required Intervention