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Catalog Number 5954450 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2020.Review of the manufacturing records is in process.When the investigation has been completed, a supplemental emdr will be submitted.
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Event Description
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It was reported that on (b)(6) 2020, while preparing a ventralight st mesh to be opened in a sterile field, it was noted that the external packaging of the mesh was intact but upon opening, there was a hole in the sealed silver packaging around the actual mesh.As reported, there was no injury or impact to the patient.There was about a 5 minute or less delay to the case as another piece of mesh was procured to complete the case.
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Event Description
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It was reported that on (b)(6) 2020, while preparing a ventralight st mesh to be opened in a sterile field, it was noted that the external packaging of the mesh was intact but upon opening, there was a hole in the sealed silver packaging around the actual mesh.As reported, there was no injury or impact to the patient.There was about a 5 minute or less delay to the case as another piece of mesh was procured to complete the case.
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Manufacturer Narrative
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At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in march 2020.Review of the manufacturing records is in process.When the investigation has been completed, a supplemental emdr will be submitted.Addendum: this is an addendum to the initial emdr submitted on (b)(6) 2020 to document the results of device evaluation.It was reported that there was a hole in the ventralight st sterile package.Evaluation of the returned sterile foil pouch confirms a tear and breach of the sterile barrier, located on the non-label side of the pouch.There was no evidence of damage observed on the outer carton.The sample provided for evaluation indicates that damage on the pouch occurred prior to performing the final packaging operation.Investigation identified the most probable cause to be damaged by force/impact during manufacturing.A review of the manufacturing records was performed and found that the lot was manufactured to specification, with no anomalies identified.Attempt to replicate the damage on the manufacturing line was unsuccessful.A definitive cause as to how the damage presented could not determined.No other complaints have been received and this appears to be unique condition limited to this single unit.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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