Model Number 309620 |
Device Problems
Leak/Splash (1354); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd¿ catheter tip syringe sterile, single use the syringe separated during use and caused leakage.There was no report of patient impact.The following information was provided by the initial reporter: many a times, the syringe will ¿pop¿ out during ng feeding especially for patients using the feeding tube, causing the milk to overflow.
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Manufacturer Narrative
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H.6.Investigation summary : there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.Dhr was performed on lot reported by the customer but this lot number is not associated with the medical device that was reported.Dhr for lot number 0244555 has been reviewed.This lot was built and packaged on nfa line 2 from (b)(6)2020 through (b)(6)2020 for a quantity of 94,090.No related quality issues or process deviation were found.
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Event Description
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It was reported while using bd¿ catheter tip syringe sterile, single use the syringe separated during use and caused leakage.There was no report of patient impact.The following information was provided by the initial reporter: ¿ many a times, the syringe will ¿pop¿ out during ng feeding especially for patients using the feeding tube, causing the milk to overflow.
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Search Alerts/Recalls
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