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 306339

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

Event Type  malfunction  

Event Description

Information was received indicating that this peripheral intravenous catheter would not penetrate the skin.It was noted that it was not possible to place the catheter in the patient and another catheter had to be used.No adverse patient effects were reported.

Manufacturer Narrative

Two used units of jelco® protectiv® safety i.V.Catheter from the same lot number as this device were returned for analysis.The units were analyzed under magnification.No defect was found.The needle was sharp and the bevel didn't show any anomaly.The wall thickness and the trim length measurement were in compliance with the internal specification.The design history record review didn't show any anomaly.The complaint database review didn't show other complaints for the referenced defect.

• 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 NORTH AMERICA; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7429574
• MDR Text Key: 105445797
• Report Number: 3012307300-2018-01130
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/27/2020
• Device Catalogue Number: 306339
• Device Lot Number: 3538378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1