Catalog Number MZ5303 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
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Event Description
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It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector iv had a loose connection to the hub of the intracath, causing contrast medium to leak out.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "new iv connector mz5303 with the white caps do not fully screw into the hub of the intracath.We have had at least 2 instances where the connection failed and the patient did not receive contrast because it leaked out.This appears to be manufactured differently than previous shipments of the same product.No harm occurred to the patient.What was the original intended procedure? : mri prostate with and without contrast".
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Event Description
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It was reported that the bd maxzero¿ multi-fuse pressure rated extension set with needleless connector iv had a loose connection to the hub of the intracath, causing contrast medium to leak out.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "new iv connector mz5303 with the white caps do not fully screw into the hub of the intracath.We have had at least 2 instances where the connection failed and the patient did not receive contrast because it leaked out.This appears to be manufactured differently than previous shipments of the same product.No harm occurred to the patient.What was the original intended procedure? : mri prostate with and without contrast".
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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 connection issues could not be verified due to the product not being returned for failure investigation.A device history record review for model mz5303 lot number 22119226 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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Search Alerts/Recalls
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