Catalog Number 383511 |
Device Problems
Break (1069); Leak/Splash (1354)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 12/09/2020 |
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 24 ga x 3/4 in single port was damaged.The following information was provided by the initial reporter: before use, the hcp noticed that the push tab was damaged.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/22/2020.H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one un-retracted unit and four photos.Upon initial inspection of the photos and the received sample, it was found that the tip shield was cracked, confirming the reported defect.The grip was inspected for any signs of damage.A minor scratch was observed on the grip, however no other major damage or indentations were found.This indicated that the damage most likely occurred during the manufacturing process.A device history record review showed no non-conformances associated with this issue during the production of this batch.
|
|
Event Description
|
It was reported that nexiva 24 ga x 3/4 in single port was damaged.The following information was provided by the initial reporter: before use, the hcp noticed that the push tab was damaged.
|
|
Search Alerts/Recalls
|