MAUDE Adverse Event Report: HUDSON BREATHING CIRC,ANES,ADULT,2.4M (96"); CIRCUIT, BREATHING (W CONNECTO

Model Number	IPN049908
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that "both the units gave an alarm of a leak in the circuit when they attached them to the same anaesthetic machine.On the third unit the issue was resolved.Clinical consequences: none - prior to use on a patient during inspection/functional testing".
Event or Problem Description
It was reported that "both the units gave an alarm of a leak in the circuit when they attached them to the same anaesthetic machine.On the third unit the issue was resolved.Clinical consequences: none - prior to use on a patient during inspection/functional testing".
Additional Manufacturer Narrative
(b)(4), the customer returned one 351600 adult breathing circuit for investigation.Upon receiving the circuit, it was visually examined for any signs of misuse/abuse/damage.No tube melting or charring was detected.A crack was found in the wye connector.The entire circuit was hooked to a leak tester and leak tested per iso standard 5367:2000, annex "d", which states that at a constant air pressure of 60 +/- 3cm h2o, the leak rate shall not exceed 30 ml/min.The leak was so profuse, a quantitative leakage value could not be recorded.The circuit leaked from the crack in the wye connector.The complaint of a leaking circuit was confirmed.The returned sample leaked air from the crack in the wye connector.It is not known how the crack occurred.There is not sufficient evidence to assure this issue was originated during the manufacturing process.It is unknown in what part of supply chain the circuit was damaged.However, personnel from quality and the production line will be notified about this complaint in order to keep them aware of the issue reported.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT,2.4M (96")
• Common Device Name: CIRCUIT, BREATHING (W CONNECTO
• MDR Report Key: 11592274
• Report Number: 3004365956-2021-00113
• Device Sequence Number: 4497098
• Product Code: CAI
• UDI-Device Identifier: 14026704641090
• UDI-Public: 14026704641090
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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
• Operator of Device: No Information
• Device Model Number: IPN049908
• Device Catalogue Number: 351600
• Device Lot Number: 74J2000993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANAESTHETIC MACHINE; ANAESTHETIC MACHINE