C.R. BARD, INC. (BASD) -3006260740 BD INTRAOSSEOUS NEEDLE SET KIT; NEEDLE, HYPODERMIC, SINGLE LUMEN
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Model Number N/A |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 126178 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (126178) have been reported from the same facility.
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Event Description
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It was reported "io needle failure recently.Needle bent during the insertion.Paramedic was on 793 on friday, (b)(6) 2022.He went to insert a 25 mm gauge io (blue) into the proximal tibia on a pt in cardiac arrest.Paramedic reported with minimal pressure applied during the procedure, the io needle bent, resulting in aborting further attempt at insertion of that particular io needle.".
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Event Description
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It was reported "io needle failure recently.Needle bent during the insertion.Paramedic was on 793 on friday, 5-20-2022.He went to insert a 25 mm gauge io (blue) into the proximal tibia on a pt in cardiac arrest.Paramedic reported with minimal pressure applied during the procedure, the io needle bent, resulting in aborting further attempt at insertion of that particular io needle.".
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent intraosseous needle is confirmed; however, the exact cause is unknown.One photograph of a 25 mm intraosseous needle was returned for evaluation.An initial visual observation of the photograph showed the needle cannula and stylet within were bent at the base of the needle.No blood residue could be seen on the sample in the returned photograph.No further damage or other details could be seen on the sample in the returned photograph.While the exact cause of the bent needle in the returned photograph could not be determined, possible contributing factors include force applied during storage, handling, or use and forceful insertion against resistance.
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Manufacturer Narrative
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The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported "io needle failure recently.Needle bent during the insertion.Paramedic was on 793 on friday, (b)(6) 2022.He went to insert a 25 mm gauge io (blue) into the proximal tibia on a pt in cardiac arrest.Paramedic reported with minimal pressure applied during the procedure, the io needle bent, resulting in aborting further attempt at insertion of that particular io needle.".
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