MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. TRACH VENT HEAT & MOISTURE EXCHANGER; Circuit, breathing (w connector, adaptor, y piece)

Model Number	IPN044418
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Codes	Pain (1994); Low Oxygen Saturation (2477)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The report states that the "incident occurred in the resuscitation room on (b)(6) 2022.The connection of the track-vent on the cannula is difficult, the gauges do not match.This makes the procedure painful for the patient.[the clinicians] observed during coughing efforts that the track-vent disconnected from the cannula which led to episodes of desaturation in the patient." further information states that "the medical intervention was to give [oxygen] back to the patient and monitor." the patient status is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Four pieces of representative sample were received.The samples were closely examined by visual inspection.Complaint reported that the tracheostomy tube does not fit into the teleflex trach-vent ref 41312.It's too difficult to attach without injuring the patient.Based on the returned samples provided, 15mm plug gauge test was conducted on the connector of the samples.The connector side is in specification.In current manufacturing procedure, iqc department will conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.The incident may have happened due to the defect on tracheostomy tube.Further study could not be conducted since the tracheostomy tube did not return for investigation.Complaint reported that tracheostomy tube does not fit into the teleflex trach-vent ref 41312.But as per gauge test conducted on returned samples, the connector met the specification.Hence, this complaint could not be confirmed.
Event or Problem Description
The report states that the "incident occurred in the resuscitation room on (b)(6) 2022.The connection of the track-vent on the cannula is difficult, the gauges do not match.This makes the procedure painful for the patient.[the clinicians] observed during coughing efforts that the track-vent disconnected from the cannula which led to episodes of desaturation in the patient".Further information states that "the medical intervention was to give [oxygen] back to the patient and monitor".The patient status is reported as "fine".

• Brand Name: TRACH VENT HEAT & MOISTURE EXCHANGER
• Common Device Name: Circuit, breathing (w connector, adaptor, y piece)
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15691344
• Report Number: 8040412-2022-00310
• Device Sequence Number: 20678788
• Product Code: CAI
• UDI-Device Identifier: 04026704348176
• UDI-Public: 04026704348176
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: Health Professional
• Device Model Number: IPN044418
• Device Catalogue Number: 41312
• Device Lot Number: KMZ21M0669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2022
• 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: N/A.; N/A.
• Patient Sex: Unknown