Catalog Number 20350E |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd alaris smartsite low sorbing extension set was kinked the following information was received by the initial reporter with the verbatim tubing is kinking at the filter.Replaced set and tubing kinked again.This happened twice on (b)(6) 2023 and once on (b)(6) 2023.
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Manufacturer Narrative
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The customer reported that the tubing is kinked.Four samples model 20350e lot 23059076 were returned for investigation.The sets were examined for defects and abnormalities.One kink was found on one sample just after the filter outlet.No other defects or abnormalities were observed.Three sets were attached to a 10 ml bd syringe filled with water and successfully primed.The customer complaint that the tubing was kinked was verified but this did not impede flow.From the manufacturer's investigation, the potential root cause of kinked tubing could be related to an incorrect coiling of the product, excess of solvent and an incomplete insertion between components by the assembler.The failure mode was addressed under the investigation for the pr 7043075.A quality alert was generated on (b)(6) 2023 to communicate and reinforce the correct assembly process to avoid gaps and incorrect coiling.The medical 15 bushing evaluation was carried out to reduce the solvent in the medical 15 solvent dispenser on (b)(6) 2023.The expander setup with compressed air in the fixtures area was carried out on (b)(6) 2023.Additionally, a work order was created and completed on (b)(6) 2023 to address issues with the medical solvent dispenser.A device history record review for model 20350e lot number 23059076 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
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Event Description
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Material#: 20350e, batch number#: 23059076.It was reported by customer that tubing is kinking at the filter.Replaced set and tubing kinked again.This happened twice on (b)(6) 23 and once on (b)(6) 23.Verbatim#: rcc received a complaint via email.Email(s) attached.Tubing is kinking at the filter.Replaced set and tubing kinked again.This happened twice on (b)(6) 23 and once on (b)(6) 23.Additional noted in email attached to this pir.Product#: 20350e, lot#: (10)23059076.Customer reply: i have the samples in my office for return.The address in my signature is where you can send the label.
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Search Alerts/Recalls
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