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Model Number 8881540111 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation.¿ if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.¿ as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported that the drug was squirting out of a small hole or crack of the monoject smartip needleless vial access cannula.There was no patient injury.
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Manufacturer Narrative
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The device history record review found that there were no related issues recorded throughout the manufacturing and control processes.The product was in conformance to specifications and was released for distribution meeting all established quality assurance acceptance levels.Two samples were returned to the manufacturing site for evaluation confirming the reported issue; the leak was identified between the connection points to the sheath, commonly referred to as the ¿ears¿ of the hub.This portion of the hub is the area with the least amount of plastic thickness.Based on this evaluation it is most likely that the condition occurred within the molding process and is indicative of inclusions within the molding process that may obstruct material flow.The investigation did not identify a systemic issue or trend with the product or process therefore, a corrective and preventive action (capa) is not necessary at this time.Further analysis will be performed to track and trend any adverse results.This information will be utilized for trending purposes to determine the need for corrective actions.
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Search Alerts/Recalls
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