MAUDE Adverse Event Report: NEXIVA 22GA X 1.00 IN DP WITH MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	383572
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that nexiva 22ga x 1.00 in dp with maxzero leaked.The following information was provided by the initial reporter: it is reported customer is experiencing leakage.Maxzero ivs that we are using do not allow us to connect and disconnect without having drips of fluid on them.I have tightened them but when we disconnect from the hub, there are still drips of liquid.We are using radioactive material for this.Also the sponge part of the hub, the activity is getting hung up in there.We have to flush it profusely.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.
Event or Problem Description
It was reported that nexiva 22ga x 1.00 in dp with maxzero leaked.The following information was provided by the initial reporter: it is reported customer is experiencing leakage.Maxzero ivs that we are using do not allow us to connect and disconnect without having drips of fluid on them.I have tightened them but when we disconnect from the hub, there are still drips of liquid.We are using radioactive material for this.Also the sponge part of the hub, the activity is getting hung up in there.We have to flush it profusely.

• Brand Name: NEXIVA 22GA X 1.00 IN DP WITH MAXZERO
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12452925
• Report Number: 9610847-2021-00431
• Device Sequence Number: 17134945
• Product Code: FOZ
• UDI-Device Identifier: 00382903835720
• UDI-Public: 00382903835720
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 383572
• Device Lot Number: 0206528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1