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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number C49291349-NLJ
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
Event Type  malfunction  
Event Description
It was reported that during a pre-use check, a crack was found in the breathing circuit.No patient injury was reported.
 
Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.A product sample and pictures were received for evaluation.Visual and functional testing were performed.It was observed in pictures that the circuit had a tear.The sample was received in used conditions without original package.The sample was visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any damage on the units, and the physical evaluation confirmed that the sample unit had a tear.The most probable root cause of the reported issue was found to be that the product became damaged after it left the manufacturing facility.No corrective actions are required since failure mode is not attributable at the manufacturing process since all products are 100% leak tested; if a tear damages a circuit surface couldn?t pass the leak test.Udi is unknown.Operator of device is unknown.Manufacturer site address is unknown.Pma/510(k) is unknown.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
 
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Brand Name
PORTEX ANESTHESIA BREATHING CIRCUIT
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section G)
NULL
MDR Report Key15445789
MDR Text Key305907600
Report Number3012307300-2022-19615
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberC49291349-NLJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/12/2022
Initial Date FDA Received09/19/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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