MAUDE Adverse Event Report: NEXIVA 20GA 1.75IN HF Y; INTRAVASCULAR CATHETER

Catalog Number	383538
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
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 20ga 1.75in hf y needle would not retract.The following information was provided by the initial reporter: we have received a delivery of some defective products.The entire box from this delivery is unusable and i also have 10 each from an earlier delivery, but not sure what po it would have been on.Not sure if it¿s entirely clear from the photos but the packaging appears to have been melted and in a number of cases has split open due to warping.
Event or Problem Description
It was reported that nexiva 20ga 1.75in hf y needle would not retract.The following information was provided by the initial reporter: we have received a delivery of some defective products.The entire box from this delivery is unusable and i also have 10 each from an earlier delivery, but not sure what po it would have been on.Not sure if it¿s entirely clear from the photos but the packaging appears to have been melted and in a number of cases has split open due to warping.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received thirty-one units and three photos.Through the visual examination, it was observed that all 31 returned units had varying levels of the deformation of the bottom web.The reported defect was confirmed.Additionally, 11 of the units were found to have an opening in the seal.Most of the 11 opened units had the highest degree of warping of all the units, likely indicating that the warping itself caused the seal to be broken.Further inspection of the opened units found that the seal adhesive was present and was uniform on the bottom web, indicating that unit had been fully sealed before the seal was broken.The observed deformed/shrunk packages are most commonly a result of exposure to extreme heat and therefore are most likely due to transit or storage.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

• Brand Name: NEXIVA 20GA 1.75IN HF Y
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12508237
• Report Number: 1710034-2021-00833
• Device Sequence Number: 5146809
• Product Code: FOZ
• UDI-Device Identifier: 00382903835386
• UDI-Public: 00382903835386
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2021

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: 09/30/2023
• Device Catalogue Number: 383538
• Device Lot Number: 0274618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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