Catalog Number 47286578 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Underdose (2542)
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Event Date 02/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation is anticipated, but has not yet begun.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 a pen ii omnitrope pen leaked about 2 to 8 drops when giving the injection.The report is as follows, "received a call from xxx (mother), she said that when she gives the injection the pen has drops come out.She is not near the pen right now.Mother stated that she sees between 2 to 8 drops come out when giving the injection.She can be contacted.".
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Manufacturer Narrative
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Investigation summary: one (1) sample was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Initial evaluation of the returned complaint sample revealed no visible damage to the pen.An injection sequence was executed using a 31g x 5mm bd pen needle and placebo cartridge.The pen was evaluated for leaking from the needle by observing the number of droplets that formed 30 seconds after needle attachment and after administering low dose, mid dose, and high dose injections.For each injection, the 30 second allowance began after a 5 second hold time at the end of injection.Investigator observed droplets forming at the needle tip during the 30 second allowance.The number of droplets observed was as follows: after needle attachment after low dose after mid dose after high dose droplets observed 5 4 2 3 based on investigation conclusion, bdm-ps was able to confirm the detection and characterize the condition reported by customer.The reported condition has been confirmed but is not defined in the applicable specification.As a consequence, bdm-ps will not conduct a full root cause analysis.However this complaint is registered in bd complaint system and trend analysis will be performed.Confirmed, not part of specification.
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Event Description
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It was reported that a pen ii omnitrope pen leaked about 2 to 8 drops when giving the injection.The report is as follows, "received a call from xxx (mother), she said that when she gives the injection the pen has drops come out.She is not near the pen right now.Mother stated that she sees between 2 to 8 drops come out when giving the injection.She can be contacted.".
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Search Alerts/Recalls
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