Catalog Number 302633 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2073245.D.4.Medical device expiration date: 28-feb-2027.H.4.Device manufacture date: 14-mar-2022.D.4.Medical device lot #: 2073242.D.4.Medical device expiration date: 28-feb-2027.H.4.Device manufacture date: 14-mar-2022.D.4.Medical device lot #: 2077110.D.4.Medical device expiration date: 31-mar-2027.H.4.Device manufacture date: 18-mar-2022.H.3.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 the plunger separated from the bd solomed¿ syringe while aspirating medicine.It was unspecified whether the event took place with lot 2073245, 2073242 or 2077110.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "customer has received complaints after market in which the end users report the syringe that goes inside the drug pack was defective in its plunger.In first occurrence, the user reports the plunger is jammed, rigid, so it was not able to aspirate the medication; in the other two occurrences, the user report that when the medication was being aspirated the plunger detached.The company also reports that the syringes are received sealed and are manually stored inside the cartons, so the odds of the issue happening inside their company (during production) are low, since there are no steps in their process that would compromise the integrity of the syringes.The batches affected in each event are unknown, but syringes' batches used in company production were: 2073245, 2073242 and 2077110.
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Event Description
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It was reported that the plunger separated from the bd solomed¿ syringe while aspirating medicine.It was unspecified whether the event took place with lot 2073245, 2073242 or 2077110.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter, translated from portuguese: "customer has received complaints after market in which the end users report the syringe that goes inside the drug pack was defective in its plunger.In first occurrence, the user reports the plunger is jammed, rigid, so it was not able to aspirate the medication; in the other two occurrences, the user report that when the medication was being aspirated the plunger detached.The company also reports that the syringes are received sealed and are manually stored inside the cartons, so the odds of the issue happening inside their company (during production) are low, since there are no steps in their process that would compromise the integrity of the syringes;.The batches affected in each event are unknown, but syringes' batches used in company production were: 2073245, 2073242 and 2077110.".
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Manufacturer Narrative
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H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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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