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 10/25/2023 |
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 the clinical nurse of the oncology department took out the infusion port needle and prepared to puncture it 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.No other information was provided.
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Event Description
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It was reported the clinical nurse of the oncology department took out the infusion port needle and prepared to puncture it 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.No other information was provided.
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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 damaged packaging is confirmed; however, the root cause could not be determined.Six photographs of 2 infusion sets were returned for evaluation.An initial visual observation of the photographs showed both infusion sets.The packaging had a small hole through the tyvek lidstock side.In one of the photographs, the safety finger tab of the infusion set was protruding out of the card insert that the infusion set is attached to.Although damaged packaging was evident in the submitted photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.
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