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

Catalog Number 19116

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that after "indwelling" a jelco® plus catheter into "the body of a patient", the user "punctured the other to the same spot and locate its catheter in it".When the catheter was being removed, they found one done earlier was torn off.No injury was reported.

Manufacturer Narrative

Upon receiving the device for investigation, it was determined that it was not a smiths medical device.

• Brand Name: JELCO® PLUS 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 HEALTHCARE MANUFACTURING SA DE CV; carretera miguel alemán km21.7; parque industrial monterrey; apodaca, nl CP 66 603; MX CP 66603
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7278262
• MDR Text Key: 100451024
• Report Number: 3012307300-2018-00259
• 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: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 19116
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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