MAUDE Adverse Event Report: NEXIVA 22GA 1.00IN Y; INTRAVASCULAR CATHETER

Catalog Number 383532

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1011111.Medical device expiration date: 2023-12-31.Device manufacture date: 2021-01-11.Medical device lot #: 1035214.Medical device expiration date: 2024-01-31.Device manufacture date: 2021-02-04.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that nexiva 22ga 1.00in y was missing the clamp.The following information was provided by the initial reporter: it was reported missing the safety cap on the needle, missing the clamp - (other), needle stick.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 1082130; d4: medical device expiration date: 2024-02-29; h4: device manufacture date: 2021-03-29.H6: investigation summary no samples were received from lots 1011111 and 1035214.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Our quality engineer inspected the samples from lot 1082130 submitted for evaluation.Bd received two units within opened packaging and one within a sealed package.During the visual examination, it was observed that the protective needle covers were missing from all three units.The defect of missing needle cover was confirmed and the root cause was determined to be manufacturing related.Preventative maintenance and quality inspections are performed at regular intervals to mitigate the risk from this type of defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that nexiva 22ga 1.00in y was missing the clamp.The following information was provided by the initial reporter: it was reported missing the safety cap on the needle, missing the clamp - (other), needle stick.

• Brand Name: NEXIVA 22GA 1.00IN Y
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12302959
• MDR Text Key: 265875936
• Report Number: 1710034-2021-00689
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835324
• UDI-Public: 00382903835324
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383532
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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