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Model Number 8881850215 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Submit date: 3/05/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer reported foreign debris on the needle.From (b)(4)-the customer reports: plastic fragments on the needles as well as missing information on the packaging.They immediately pulled stock and inspected the products.The plastic fragments were not isolated to 1 or 2 lots, but all lots.From (b)(4) -the customer reports: plastic fragments on the needles as well as missing information on the packaging.They immediately pulled stock and inspected the products.The plastic fragments were not isolated to 1 or 2 lots, but all lots.On (b)(6) 2018, additional information was received stating that there is excess oil or grease residue on the needles.
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Manufacturer Narrative
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A review of the device history records (dhr)¿s for the reported lot indicates that there were no issues noted during manufacturing of the lot.There were no devices returned to our facility for evaluation, therefore the reported issue and root cause could not be confirmed.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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