Catalog Number 305541 |
Device Problem
Defective Component (2292)
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Patient Problem
Pain (1994)
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Event Date 06/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd¿ allergy syringe experienced defective plunger.No serious injury reported.The following information was provided by the initial reporter: some of the plungers were malformed.
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Event Description
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It was reported that the bd¿ allergy syringe experienced defective plunger.No serious injury reported.The following information was provided by the initial reporter: some of the plungers were malformed.
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Manufacturer Narrative
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H.6.Investigation summary: photos and (1195) 1ml, 10mm, 27g bd allergy syringes (1125 in sealed trays, 70 in open trays) were received along with the reported complaints of plunger rod broken/damaged.The investigating team has used the photos and samples of item #305541 and lot #2011725 for investigating the reported defects.The photos and thirty out of 1195 returned syringes were examined and no damaged plunger rod were observed.All observations fell within specifications.A review of the device history record was completed for batch #2011725.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples and/or photo(s) received the investigation concluded that embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issues are unconfirmed.
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Search Alerts/Recalls
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