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

Catalog Number 4013-AI

Device Problems Bent (1059); Difficult or Delayed Positioning (1157)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the cannulas of a jelco® i.V.Catheter bend/snap right after implementation.There was no patient injury related to the event.

Manufacturer Narrative

Additional information was received indicating that a smiths medical jelco® i.V.Catheter bent twice directly when advancing the catheter.It was reported that the material is noted to be thinner and more rigid than normal.The patient was reported to be fine.

Manufacturer Narrative

85 unused units were returned for evaluation.Of the 85, 20 were visually insepected.Four units were found to have a bevel not correctly molded, and catheter contour that exceeded the lower specification limit.The reported customer complaint has been confirmed.The root cause has been determined to be related to an assembly line issue.

• Brand Name: JELCO® 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
• MDR Report Key: 7556961
• MDR Text Key: 109746132
• Report Number: 3012307300-2018-01994
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2022
• Device Catalogue Number: 4013-AI
• Device Lot Number: 3449020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/31/2018
• Supplement Dates Manufacturer Received: 06/04/2018; 01/16/2019
• Supplement Dates FDA Received: 07/03/2018; 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1