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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; FILTER, BACTERIAL, BREATHING-CIRCUIT
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MEDLINE INDUSTRIES, INC. MEDLINE; FILTER, BACTERIAL, BREATHING-CIRCUIT Back to Search Results
Model Number DYNJAA10429
Device Problems Break (1069); Crack (1135); Connection Problem (2900); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2021
Event Type  malfunction  
Event Description
The breathing bag included in the anesthesia adult circuit set had issues with the plastic connector piece.The piece cracked and impaired the function of the breathing bag.The anesthesia machine with the breathing bag originally passed safety checks prior to procedure, and then broke after being put in use.Manufacturer response for anesthesia adult circuit- lf, medline (per site reporter).The operating room anesthesia support tech notified the medline representative directly of the concern.Medline offered a potential solution to mitigate the concern but using a different breathing bag that has a softer rubber connector piece.This alternate breathing bag is called bag breathing 3l soft-lf.The original device was not sequestered by the support tech, and i was notified at a later time of the product issue.
 
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Brand Name
MEDLINE
Type of Device
FILTER, BACTERIAL, BREATHING-CIRCUIT
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
1 medline place
mundelein IL 60060
MDR Report Key12224324
MDR Text Key263403356
Report Number12224324
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberDYNJAA10429
Device Catalogue NumberDYNJAA10429
Device Lot Number20LBV320
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2021
Event Location Hospital
Date Report to Manufacturer07/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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