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

Catalog Number 326010

Device Problem Difficult to Advance (2920)

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

Event Type  malfunction  

Manufacturer Narrative

See mfr: 3012307300-2018-00833, 3012307300-2018-00879, 3012307300-2018-00880, 3012307300-2018-00881, 3012307300-2018-00882, 3012307300-2018-00883.

Event Description

It was reported that the smiths medical device "blood return big veins" and the device was hard to slide.It was indicated that a nurse blew a vein.No other information was provided.

Manufacturer Narrative

One used deployment chassis and beveled catheter assembly was returned for investigation.Examination of the returned device via microscopy did not reveal any evidence of unusual leakage.The deployment chassis was very clean.The nose area was also very clean, the flash chamber showed little evidence of blood, however blood was present.The beveled catheter assembly was intact with the seal deployed over the actuator as if it had been connected to an iv set, however there is no evidence of an iv set attachment in the description or the returned device.The seal itself was extracted and examined for seal slit.The seal appeared to be slit off center, and did exhibit a significant tear on one of the three legs.This could have potentially leaked prior to seal deployment however since the seal was deployed as returned, the condition of the seal prior to deployment is indeterminate.The complaint could not be confirmed.

• Brand Name: JELCO® VIAVALVE® SAFETY IV 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 ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7381759
• MDR Text Key: 103834698
• Report Number: 3012307300-2018-00833
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: 15019517078398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/30/2020
• Device Catalogue Number: 326010
• Device Lot Number: 3549778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• 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