MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 20GA 1.25IN HF Y; INTRAVASCULAR CATHETER

Catalog Number 383537

Device Problem Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that nexiva 20ga 1.25in hf y package was damaged.This occurred on 11 occasions.The following information was provided by the initial reporter: this is a report about damaged packages.According to the customer's report, the package component (plastic tray) was damaged (deformed) in 11 of 20 products.(additional information on 02/03/2021).The periphery of the package tray was partly deformed sharply (upper part) or cut diagonally (lower part) and the customer is questioning whether sterilization of the package has been guaranteed.

Event Description

It was reported that nexiva 20ga 1.25in hf y package was damaged.This occurred on 11 occasions.The following information was provided by the initial reporter: this is a report about damaged packages.According to the customer's report, the package component (plastic tray) was damaged (deformed) in 11 of 20 products.(additional information on 02/03/2021) the periphery of the package tray was partly deformed sharply (upper part) or cut diagonally (lower part) and the customer is questioning whether sterilization of the package has been guaranteed.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/16/2021.H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received eleven unopened units and seven photos.During the visual examination of the units and photos, it was observed that excess material and sharp edges were present confirming the reported defect.Misalignment or incorrect setup during the cutting process may result in excess material like that observed in the returned units resulting in sharp edges; therefore, the most probable root cause is manufacturing.The seal width was measured to determine if a sufficient seal was made.All eleven seals were found to be within specification indicating that the sterility was not affected by the defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: NEXIVA 20GA 1.25IN HF Y
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11370289
• MDR Text Key: 233568574
• Report Number: 1710034-2021-00140
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: 00382903835379
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 383537
• Device Lot Number: 0168884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1