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

Catalog Number 308500

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information was received that a smiths medical catheter had resistance upon removal.Half of the catheter was missing when it was removed from the patient.This piece was removed the following day.

• Brand Name: SMITHS MEDICAL 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
• Manufacturer (Section G): SMITHS MEDICAL ASD; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8081921
• MDR Text Key: 127531696
• Report Number: 3012307300-2018-08189
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071309
• UDI-Public: 10351688071309
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 308500
• Device Lot Number: 3616862
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1