Model Number 309597 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9076761, medical device expiration date: 2024-02-29, device manufacture date: 2019-03-17, medical device lot #: 8221735, medical device expiration date: 2023-07-31, device manufacture date: 2018-08-09.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 has been reported that the bd¿ syringe 1ml s/t w/ndl 26x5/8 rb has been found experiencing two occurrences of clogged needles during use.The following has been provided by the initial reporter: it was reported that when the patient would draw back the needle to obtain medication, nothing would go through the needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.It was reported: patient advised she was not able to draw up medication today with 2 needles.When patient would draw back needle to obtain medication, nothing would go through needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.
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Event Description
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It has been reported that the bd¿ syringe 1ml s/t w/ndl 26x5/8 rb has been found experiencing two occurrences of clogged needles during use.The following has been provided by the initial reporter: it was reported that when the patient would draw back the needle to obtain medication, nothing would go through the needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.It was reported: patient advised she was not able to draw up medication today with 2 needles.When patient would draw back needle to obtain medication, nothing would go through needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.
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Manufacturer Narrative
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H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Search Alerts/Recalls
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