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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL H-V FILTER SMALL STRAIGHT, STERILE; CONDENSER, HEAT AND MOISTURE
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TELEFLEX MEDICAL H-V FILTER SMALL STRAIGHT, STERILE; CONDENSER, HEAT AND MOISTURE Back to Search Results
Catalog Number G19501
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "when the user tried to connect the device to an anesthesia circuit, it got broken in two.Therefore, a new unit was used instead." no patient injury reported.The condition of the patient is listed as "fine".
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample was detached.Ten pieces of the same catalog number were taken from current production at the manufacturing facility to inspect for the reported defect.No visual issues were observed and all ten samples passed leak and pull testing.Pull test results showed no detachment between the dry side and wet side of the product.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.In the current manufacturing procedure, 100% leak testing during the assembly process and 100% visual inspection is conducted at the packing area.Any defective products would be detected prior to release from the manufacturing facility.A root cause for the defect could not be established.
 
Event Description
The complaint is reported as: "when the user tried to connect the device to an anesthesia circuit, it got broken in two.Therefore, a new unit was used instead." no patient injury reported.The condition of the patient is listed as "fine".
 
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Brand Name
H-V FILTER SMALL STRAIGHT, STERILE
Type of Device
CONDENSER, HEAT AND MOISTURE
Manufacturer (Section D)
TELEFLEX MEDICAL
perak, west malaysia
MDR Report Key8915410
MDR Text Key155055529
Report Number8040412-2019-00222
Device Sequence Number1
Product Code BYD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberG19501
Device Lot Number19AT21J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2019
Date Manufacturer Received09/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ANESTHESIA CIRCUIT; ANESTHESIA CIRCUIT; ANESTHESIA CIRCUIT
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