BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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Catalog Number 306593 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E.1 initial reporter phone #: (b)(6).H.6 investigation summary: it was reported the end section of the flusher piston rod is deformed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a prefilled syringe in its packaging flow wrap with the top part of the plunger rod damaged.No other defects or imperfections were observed.This defect could occur if the sample was not placed in the correct position when the flow wrap cutter went to cut the flow wrap.A device history record review was completed for provided material number 306593, lot 2096908.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the packaging flow wrapper process was performed.The settings were correct and the space between units was good.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 is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd pre-filled normal saline syringe damage.The following information was provided by the initial reporter, translated from japanese to english: after infusion, the nurse pre-flushes the patient's indwelling needle catheter, opens the outer packaging of the pre-filled catheter flusher, and finds that the end section of the flusher piston rod is deformed and cannot be used normally.
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