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

Catalog Number 18520

Device Problems Positioning Failure (1158); Dull, Blunt (2407); Material Integrity Problem (2978)

Patient Problem Discomfort (2330)

Event Date 03/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that immediately after using a jelco® jelco® i.V.Catheter, the health care provider noticed that the needle tip was dull.It caused the patient to feel pain and would not allow them to use it normally.No patient injury.

Manufacturer Narrative

One smiths medical jelco® i.V.Catheter was returned for analysis.Visual analysis revealed that the needle was intact.However, the bevel was damaged; consistent with improper use.Manufacturing process was reviewed indicating that bevel damage of this severe would have been identified upon release.Based on the evidence, the failure result was found to be user error by using the product in a manner inconsistent with the instructions for use (ifu).

• Brand Name: JELCO® JELCO® I.V. CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4; parque industrial internaciona; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7466411
• MDR Text Key: 106713753
• Report Number: 3012307300-2018-01004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

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 Catalogue Number: 18520
• Device Lot Number: 3433038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1