Catalog Number UNKNOWN |
Device Problems
Short Fill (1575); Defective Component (2292)
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Patient Problem
Unspecified Respiratory Problem (4464)
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Event Date 11/29/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the unspecified bd arterial blood collection syringe, the device experienced insufficient blood flow through device from via difficult plunger movement.The following information was provided by the initial reporter.The customer stated: report of adverse event with gas syringe.4.Female (b)(6), number 2: (b)(6) with a diagnosis of tpn at 35 weeks with adequate weight for gestational age, respiratory distress syndrome with oxygen requirement for nasal cpap, with indication to take arterial blood gases for admission and control, who was punctured repeatedly due to difficult obtaining a sample since the syringe does not allow the blood to return more than 1cc.Patient with ecchymosis at puncture sites to whom magnesium sulfate compresses were applied.
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Manufacturer Narrative
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Date of event: unknown.Medical device expiration date: unknown.Initial reporter city: since the city is (b)(6) will be used as its place holder until further updated by the customer.Initial reporter country : unknown united states was used until further updated.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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Date of event: unknown.Medical device expiration date: unknown.Initial reporter city: since the city is (b)(6) will be used as its place holder until further updated by the customer.Initial reporter country : unknown united states was used until further updated.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the unspecified bd arterial blood collection syringe, the device experienced insufficient blood flow through device from via difficult plunger movement.The following information was provided by the initial reporter.The customer stated: report of adverse event with gas syringe.Female (b)(6), number 2: (b)(6) with a diagnosis of tpn at 35 weeks with adequate weight for gestational age, respiratory distress syndrome with oxygen requirement for nasal cpap, with indication to take arterial blood gases for admission and control, who was punctured repeatedly due to difficult obtaining a sample since the syringe does not allow the blood to return more than 1cc.Patient with ecchymosis at puncture sites to whom magnesium sulfate compresses were applied.
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Manufacturer Narrative
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H6: investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
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Event Description
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It was reported when using the unspecified bd arterial blood collection syringe, the device experienced insufficient blood flow through device from via difficult plunger movement.The following information was provided by the initial reporter.The customer stated: report of adverse event with gas syringe.4.Female newborn, number 2: newborn with a diagnosis of tpn at 35 weeks with adequate weight for gestational age, respiratory distress syndrome with oxygen requirement for nasal cpap, with indication to take arterial blood gases for admission and control, who was punctured repeatedly due to difficult obtaining a sample since the syringe does not allow the blood to return more than 1cc.Patient with ecchymosis at puncture sites to whom magnesium sulfate compresses were applied.
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Search Alerts/Recalls
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