Catalog Number UNKNOWN |
Device Problems
Leak/Splash (1354); Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the unspecified bd infusion set experienced kinked tubing, flow issues, and leakage.The following information was provided by the initial reporter: we are seeing ¿defective¿ infusion pump sets.The tubing coming out of the drip chamber is crimped (bent) and impeding the flow out of the drip chamber.We are also seeing leaks in the tubing at this crimp area as well.It looks like this is creating a weak spot in the tubing and forcing the solution past the crimped tubing is causing leaks.We are using this tubing for chemo and optima sets.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.The customer complaint of tubing kinked - flow issues - fluid blockage-leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Event Description
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It was reported that the unspecified bd infusion set experienced kinked tubing, flow issues, and leakage.The following information was provided by the initial reporter: we are seeing ¿defective¿ infusion pump sets.The tubing coming out of the drip chamber is crimped (bent) and impeding the flow out of the drip chamber.We are also seeing leaks in the tubing at this crimp area as well.It looks like this is creating a weak spot in the tubing and forcing the solution past the crimped tubing is causing leaks.We are using this tubing for chemo and optima sets.
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Search Alerts/Recalls
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