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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 C45101344-NLJ
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any damage on the unit.The elbow is broken.The reported issue is confirmed.Relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities.Based on the analysis conducted in the sample provided, the failure could not be reproduced, therefore according with the pfmea the occurrence for this failure condition could be caused by: material damage during process handling.All mitigations on placed were verified and it was confirmed that it has been executing according, therefore no corrective actions could be implemented, this failure condition will be monitor in this product for threshold or escalation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.
 
Event Description
It was reported that during a pre-use check, the customer noticed the gas sampling port was broken.No patient injury was reported.
 
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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 Key15410904
MDR Text Key305893773
Report Number3012307300-2022-18947
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 09/13/2022
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 Expiration Date12/16/2022
Device Catalogue NumberC45101344-NLJ
Device Lot Number3923191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/08/2022
Initial Date FDA Received09/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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