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

Catalog Number 306501

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2018

Event Type  Injury  

Event Description

Information was received that a smiths medical catheter was stuck in the patient's arm.Upon removal, was met with resistance and a defect of the product was described as " the tip of the catheter looks bad".The iv site was noted to bleed slightly more than normal.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8219757
• MDR Text Key: 132148989
• Report Number: 3012307300-2019-00053
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071163
• UDI-Public: 10351688071163
• 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: 01/04/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 306501
• Device Lot Number: 3678229
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/04/2019
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention