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 306001

Device Problems Difficult to Insert (1316); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

One unused jelco® protectiv® safety i.V.Catheter was returned for investigation.The complainant returned one unused device still sealed in its blister package for evaluation.Sample was visually examined and found to be acceptable with no evidence of kink catheter noted.Root cause: examination of the returned sample did not identify any reported nonconformances.Investigation conclusion: based on this investigation, the reported complaint is not confirmed.

Event Description

It was reported that a jelco® protectiv® safety i.V.Catheter kinked at the hub when inserted in the patient, causing blockage.No injury was reported.

• 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 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: 7236834
• MDR Text Key: 98854496
• Report Number: 3012307300-2018-00204
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071187
• UDI-Public: 10351688071187
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Catalogue Number: 306001
• Device Lot Number: 3423806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1