Catalog Number 309653 |
Device Problems
Break (1069); Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that before use of the bd 60ml syringe luer-lok¿ tip the barrel was cracked and broken.The plastic parts of the syringe peeled upward from the cracks.There were 35 occurrences.The following information was provided by the initial reporter: foreign matter (plastic).
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Event Description
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It was reported that before use of the bd 60ml syringe luer-lok¿ tip the barrel was cracked and broken.The plastic parts of the syringe peeled upward from the cracks.There were 35 occurrences.The following information was provided by the initial reporter: foreign matter(plastic).
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Manufacturer Narrative
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H.6.Investigation: one (1) sample and three (3) photos were provided by the customer for investigation.The sample was returned in an unopened blister pack and was visually examined.It was observed that there is piece of the plunger rod rib broken off and that there also are a pair of gashes or nicks in the side of the barrel.These gashes are parallel to each other and are consistent with a hard edge being forcibly smashed into the side of the barrel.While these gashes do not penetrate through the side of the barrel the force has bowed the barrel side inward to an extent that the plunger rod and stopper will not move past that section of the barrel.The three (3) photos provided by the customer show the broken plunger rod rib in one (1) photo.A second (2nd) photo shows eight (8) syringes in blister packs.The third (3rd) photo shows the gashes in the side of the barrel.Plunger rods are fed through a chute to the assembly process.If the chute is empty, the plunger rods can experience excessive force when falling through the entire chute causing damage to the ribs and breakage.Based on the damage to the barrel it appears that the barrel was contacted by a hard edge which resulted in the damage seen in the returned sample.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.
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Search Alerts/Recalls
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