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

Catalog Number SR-FVP2416PS

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned, so a detailed analysis could not be conducted however pictures of the shelf pack boxes with the torn / stuck label were sent back and examined.Based on a visual examination of the pictures, it is apparent that the box label from one shelf pack box became adhered to another shelf pack box.It is most likely that this could have occurred during the packaging process and that the label from one box was not fully adhered to the shelf pack box when it was placed in the shipper box.Smiths medical personnel has been made aware of this incident.Smiths medical will continue monitoring complaints and will performed corrective actions accordingly.

Event Description

It was reported that when the customer opened the outer box of the jelco safety via valve catheters, they picked up the inner box and noticed that a part of the indication label was stuck to a neighboring inner box.The label was also torn.No damage was observed in the outer box.

• Brand Name: JELCO SAFETY VIAVALVE 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 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: 7716036
• MDR Text Key: 114936068
• Report Number: 3012307300-2018-02908
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/13/2020
• Device Catalogue Number: SR-FVP2416PS
• Device Lot Number: 3588635
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• 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