MAUDE Adverse Event Report: HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT; CIRCUIT, BREATHING (W CONNECTO

Model Number	IPN049872
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
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 "the breathing bag for anesthesia did not inflate during a pretest before use.Therefore, a new unit was used instead".No patient involvement reported.
Event or Problem Description
It was reported that "the breathing bag for anesthesia did not inflate during a pretest before use.Therefore, a new unit was used instead".No patient involvement reported.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one 7140 adult breathing circuit set containing the circuit and bag.Visual inspection of the bag revealed a cut near the connector.The cut was smooth consistent with contact with sharps such as a scalpel or scissors.The bag was connected to an air supply to functionally test.The bag was able to inflate but air was found to leak out of the cut in the bag.The generic anesthesia breathing circuit ifu instructs the user, "before use, test the circuit according to instructions provided by the manufacturer of the gas monitoring equipment.If supplied, attach the breathing bag to the bag connection of the appropriate equipment interface." the complaint of a circuit bag not inflating was confirmed based on an investigation of the returned sample.Visual inspection of the bag revealed a cut near the connector.The cut was smooth consistent with contact with sharps such as a scalpel or scissors.When the bag was functionally tested, air was found to leak out of the cut in the bag.Since this product code is inspected 100% before leaving the manufacturing facility, it is unlikely that the failure was present at the time of release.A device history record review did not reveal any manufacturing related issues.Based on the sample returned it was determined that unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTO
• MDR Report Key: 12381027
• Report Number: 3004365956-2021-00264
• Device Sequence Number: 11747036
• Product Code: CAI
• UDI-Device Identifier: 14026704641410
• UDI-Public: 14026704641410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: IPN049872
• Device Catalogue Number: 7140
• Device Lot Number: 74G2000248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• 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