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Model Number 21-7052-24 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that smiths medical extension lines occluding.No injury.
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Manufacturer Narrative
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Other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H4: device manufacture date: updated.D10: device available for evaluation: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in good condition, all was intact, no physical damage present that could have cause the failure mode reported.The customer reported problem was not verified/duplicated.During the test, no occluded samples were found, and the water flowed without problem.The complaint was not confirmed.The root cause of the reported problem was unknown.No corrective actions were taken since the complaint was not confirmed.The lot was manufactured with 6,750 units, lot met the requirements to release the lot with no deviations identified during their manufactured., corrected data: correction: h4: mfg.Date.09-sep-2021.Correction: d4: expiration date 22-aug-2026.
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Manufacturer Narrative
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Event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H4: device manufacture date: updated.D10: device available for evaluation: updated.H10: device evaluation: the device was returned for investigation.Visual inspection and functional tests were performed.The customer reported problem was not related to any previous repair.Visual inspection found the device in good condition, all was intact, no physical damage present that could have cause the failure mode reported.The customer reported problem was not verified/duplicated.During the test, no occluded samples were found, and the water flowed without problem.The complaint was not confirmed.The root cause of the reported problem was unknown.No corrective actions were taken since the complaint was not confirmed.The lot was manufactured with 6,750 units, lot met the requirements to release the lot with no deviations identified during their manufactured., corrected data: correction: h4: mfg.Date.09-sep-2021 correction: d4: expiration date 22-aug-2026.
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Search Alerts/Recalls
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