|
Catalog Number 1832G |
Device Problem
Component Incompatible (1108)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/20/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: please explain the issue: was the needle shaped half circle but appeared distorted or the needle had completely different shape; for example: straight? no further information is available.Did the 4 involved devices come from 1 box of sample? no further information is available.Are actual devices being returned? yes.Device return status/ follow up : when we send the sample to you, we will let you know its return date and tracking number.No further information will be provided.Events reported in: 2210968-2019-87644, 2210968-2019-87646, 2210968-2019-87647.
|
|
Event Description
|
It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.During the procedure, when opening the package, it was found that the shape of needle was not 1/2 circle.The product was not used for the patient.There were no adverse consequences to the patient.No additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.It was reported product mix / incorrect component.One unused opened sample of product code 1832, lot pbq525 was received for analysis.During visual inspection of the sample, the swage and attachment area were noted to be as expected.The body needle was examined and the curve is smooth and continue.In addition, the needle was compared with the specification and meet the curve tolerance shadow lines and ½ circle.Also, the suture was dispensed without problems and examined along of the strand and no defects or damage were observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, no product mix / incorrect component was found.
|
|
Search Alerts/Recalls
|
|
|