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Catalog Number 0117070 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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As reported, after opening the package of a bard/davol perfix light plug on (b)(6) 2021, the mesh was noted to be frayed.The mesh was not used on the patient.There was no reported patient injury.
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Manufacturer Narrative
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As reported, perfix light plug was found to be frayed upon opening the package.The subject device was returned for evaluation.Initial evaluation finds the sample to be unused with no evidence of excessive handling or manipulation with no visible contamination found.Visual evaluation finds that one of the monofilament threads of the mesh structure may have become untied / loosened resulting in what looks like frayed material.The sample evaluation is ongoing at this time.When sample evaluation is completed, a supplemental mdr will be submitted to document the result of sample evaluation.Review of manufacturing records indicates the product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of 525 units released for distribution in june, 2021.
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Manufacturer Narrative
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As reported, perfix light plug was found to be frayed upon opening the package.The subject device was returned for evaluation.Initial evaluation finds the sample to be unused with no evidence of excessive handling or manipulation with no visible contamination found.Visual evaluation finds that one of the monofilament threads of the mesh structure may have become untied / loosened resulting in what looks like frayed material.The sample evaluation is ongoing at this time.When sample evaluation is completed, a supplemental mdr will be submitted to document the result of sample evaluation.Review of manufacturing records indicates the product was manufactured to specification.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2021.Addendum: this is an addendum to the initial mdr submitted to document the results of device evaluation.The sample evaluation identified a loose monofilament on the returned sample.Based on the investigation performed and sample evaluation, the root cause is determined to be manufacturing related.Awareness training was provided to all manufacturing personnel.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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Event Description
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As reported, after opening the package of a bard/davol perfix light plug on (b)(6) 2021, the mesh was noted to be frayed.The mesh was not used on the patient.There was no reported patient injury.
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Search Alerts/Recalls
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