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

Model Number IPN049872

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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 Description

It was reported that "air leaked from the respiratory tube during the test before use".No patient involvement reported.

Event Description

It was reported that "air leaked from the respiratory tube during the test before use".No patient involvement reported.

Manufacturer Narrative

Qn #(b)(4).The customer returned one 7140 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.The sample was received without its original packaging.The sample appears typical upon initial inspection.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 +- 3 cmh2o, the leak rate shall not exceed 30 ml/min.The leak was so profuse, a quantitative leakage value could not be recorded.The circuit was then submerged under water to identify the location of the leak.It was found that the circuit was leaking from a cut near one of its connectors.The cut went through multiple rings on the exterior of the circuit.The complaint of a leaking circuit was confirmed.The returned sample leaked air from a cut near one of the connectors on the circuit.The circuits are 100% leak tested at the manufacturing site so it is unlikely that this defect would have occurred during the manufacturing process.The dhr was reviewed with no evidence to suggest that this is a manufacturing related issue.It is unknown exactly how and when the cut occurred.Therefore, the root cause for this complaint is undetermined.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12737949
• MDR Text Key: 279583661
• Report Number: 3004365956-2021-00296
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 14026704641410
• UDI-Public: 14026704641410
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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
• 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: 10/26/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1