Catalog Number 300771 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Reaction (2414)
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Event Date 07/04/2017 |
Event Type
Injury
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Manufacturer Narrative
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For devices without 510(k) numbers: pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(b)(6).Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6355431.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.(b)(4).
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Event Description
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It was reported a customer stated when using a bd luer-lok¿ 1-ml syringe 26gx5/8in "that lots of anaphylactic reaction occurred when skin test, not anaphylactic shock.No medical intervention.The solution were penicillin and cephalosporins.Patients who had anaphylactic reaction changed to use other drug, no further skin test was carried on.Hospital claimed that 6 to 7 anaphylactic reactions were occurred every day.".
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Manufacturer Narrative
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Investigation: four representative samples in sealed package were returned for investigation.All the samples were subjected to visual inspection and inspected for the following: package integrity was checked and no damage observed on the packaging.Syringe and needle hub were inspected for foreign matter and no abnormality observed.Cannula was inspected and observed gel (lubrication) on 1 representative samples.No abnormality observed on the other 3 representative sample.Conclusion: the gel (lubrication) was sent for fourier transform infrared spectroscopy (ftir) test to match with the silicon lubrication used in the manufacturing.The ftir results shows that the gel on cannula have similar spectrum with that of the silicon lubrication used in the manufacturing.
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Search Alerts/Recalls
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