Catalog Number 309572 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2022 |
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.The customer's address is unknown.Illinois, usa has been used as a placeholder based on the reported phone area code.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 bd luer-lok¿ syringe with the bd precisionglide¿ needle was blocked during use.The following information was provided by the initial reporter: "we have used 7 needles out of this batch.The one i used tonight i needed to use all my power to push down.I couldn't give him the rest of the needed medicine because it wouldn't move.".
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Event Description
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It was reported that the bd luer-lok¿ syringe with the bd precisionglide¿ needle was blocked during use.The following information was provided by the initial reporter: "we have used 7 needles out of this batch.The one i used tonight i needed to use all my power to push down.I couldn't give him the rest of the needed medicine because it wouldn't move.".
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Manufacturer Narrative
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H.6.Investigation summary: it was reported the needle is blocked.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two packaging blister top webs.A device history record review was completed for provided material number 309572, lot number 1342380.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 1342380 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without the physical sample analysis a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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