MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF 6/CS; BOTTLE, COLLECTION, VACUUM

Model Number	IPN028442
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon arrival the patient was showing an air leak.The md tested various points in the lines and system.It was determined that the blue connector closest to the pleur-evac box was malfunctioning.A new pleur-evac box was exchanged for the original and the air leak was no longer present.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.The device history review could not be conducted since the lot number was not provided.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn# (b)(4).The device history record of batch number 74b2200767 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74b2200767 was received for analysis.Sample wasn't received in its original packaging.The ats connector (p/n 152753) was received with the red and blue connector disconnected, the o-ring (p/n 154589) was inspected, and no issues were found that can lead to the issue reported.Suction port was connected to a suction source at 60 cm h2o and patient tube was put in warm water (with blue dye.Suction was activated and collection chambers were filled with water, during this test no leaks were observed on ats connector (p/n 152753).In summary, customer complaint cannot be confirmed since no problem found on sample.
Event or Problem Description
It was reported that upon arrival the patient was showing an air leak.The md tested various points in the lines and system.It was determined that the blue connector closest to the pleur-evac box was malfunctioning.A new pleur-evac box was exchanged for the original and the air leak was no longer present.

• Brand Name: PE ADULT-PED DRY/ WET LF 6/CS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15619122
• Report Number: 3004365956-2022-00077
• Device Sequence Number: 7974955
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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 Expiration Date: 02/14/2025
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74B2200767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown