C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2023 |
Event Type
malfunction
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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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
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Event Description
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It was reported when the clinical nurse of the oncology department took out the infusion port needle and prepared to puncture, she found that the back of the package was punctured by the safety needle wing inside, and the clinical thought that the sterile packaging inside had been destroyed and could not be used.
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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 complaint of the device perforating the packaging was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 20ga x 0.75¿ powerloc safety infusion set package.The image showed the tyvek lidstock with the package label.One clear safety mechanism finger tab was visible protruding from a perforation in the lidstock and label.The infusion set safety finger tab was visible protruding from the packaging; however, it could not be determined how that perforation occurred.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include handling and storage conditions.
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Event Description
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It was reported when the clinical nurse of the oncology department took out the infusion port needle and prepared to puncture, she found that the back of the package was punctured by the safety needle wing inside, and the clinical thought that the sterile packaging inside had been destroyed and could not be used.
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Search Alerts/Recalls
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