MAUDE Adverse Event Report: TELEFLEX MEDICAL PLEUR-EVAC CHEST DRAINAGE SYSTEM; BOTTLE, COLLECTION, VACUUM

Catalog Number	S-1100-08LF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74b2201471 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance 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.
Event or Problem Description
The team in cardiology ((b)(6)) has experienced major leaking pleur-evac at the junction of the red/blue connector from lot 74b2201471.It appears that 2 pleur-evacs from the same lot had the same issue.When they used a different set from a different lot, there was no leak.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74b2201471 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Manufacture date: 2022-02-18.Expiration date: 2025-02-17.One unit of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) lot 74b2201471 was received for analysis.Sample wasn't received in its original packaging.The ats connectors p/n 152753 was received disconnected.The oring p/n 154589 was visually inspected and no issues were observed.The tubing with the ats connector (p/n 152753) was disconnected from pe unit.One side of tubing was connected to a source of air (nlc09684 due:22-sep-23) and the other side was clamped.The ats connector was immerse into the water and no bubbles were observed that can confirmed a leak.Customer complaint cannot be confirmed since no problem was found on sample.
Event or Problem Description
The team in cardiology (k2) has experienced major leaking pleur-evac at the junction of the red/blue connector from lot 74b2201471.It appears that 2 pleur-evacs from the same lot had the same issue.When they used a different set from a different lot, there was no leak.

• Brand Name: PLEUR-EVAC CHEST DRAINAGE SYSTEM
• 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: 14220467
• Report Number: 3004365956-2022-00035
• Device Sequence Number: 4194774
• Product Code: KDQ
• UDI-Device Identifier: 44026704428906
• UDI-Public: 44026704428906
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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: 02/17/2025
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74B2201471
• 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: 04/14/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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.
• Patient Sex: Unknown