SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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Catalog Number MP5303-C |
Device Problems
Leak/Splash (1354); Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Address information was not able to be obtained, therefore, nj was used as a place holder.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd maxplus pressure rated extension set with removable needleless connector blood backflowed and leaked.There was no report of patient impact.The following information was provided by the initial reporter: "when hooking j loop to patients iv, the blood backflowed up the loop, but was unable to flush.So when hooked up to the fluid bag, it just leaked around the connector site, and no fluids ran through j loop.".
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Event Description
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It was reported while using bd maxplus pressure rated extension set with removable needleless connector blood backflowed and leaked.There was no report of patient impact.The following information was provided by the initial reporter: "when hooking j loop to patients iv, the blood backflowed up the loop, but was unable to flush.So when hooked up to the fluid bag, it just leaked around the connector site, and no fluids ran through j loop.".
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Manufacturer Narrative
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H6: investigation summary no product or photo was returned by the customer.It was reported by the customer "when hooking j loop to patients iv, the blood backflow up the loop, but was unable to flush.So when hooked up to the fluid bag, it just leaked around the connector site, and no fluids ran through j loop" could not be verified due to the product not being returned for failure investigation.A device history record review for model mp5303-c and lot number 22109064 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.H3.
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