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

Catalog Number	326310
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See mfr: 3012307300-2018-00833, 3012307300-2018-00879, 3012307300-2018-00880, 3012307300-2018-00881, 3012307300-2018-00882, 3012307300-2018-00883.
Event or Problem 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.
Additional 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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7381758
• Report Number: 3012307300-2018-00880
• Device Sequence Number: 19267724
• Product Code: FOZ
• UDI-Device Identifier: 15019517078404
• UDI-Public: 15019517078404
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 326310
• Device Lot Number: 3471685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1