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

Catalog Number 326000

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

It was reported that during the catheter removal, the user noted that tube was damaged: a piece of the tube was missing at the distal extremity.An x-ray of the left arm of the patient showed that a radiopaque fragment (consistent with the missing piece of the catheter) was present in the elbow.

• Brand Name: JELCO SAFETY VIAVALVE 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 NORTH AMERICA; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7953794
• MDR Text Key: 123302607
• Report Number: 3012307300-2018-04117
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688077448
• UDI-Public: 10351688077448
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: 326000
• Device Lot Number: 3528706
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR