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

Model Number	IPN028485
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.
Event or Problem Description
Damage to the sample port area out of the package causing system air leak that required additional taping of connections not usually required.The damage was not found prior to connecting to the patient and there was no package damage.The damage and the air leak occurred at the red/blue connectors.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74b2200791 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.One unit of catalog number s-1102-08lf (pe sahara dry suct/dry seal dual lf 6) lot 74b2200791 was received for analysis.The unit shows sing of use since residues were found into the chambers.Per complaint description it was put tape on connector "additional taping of connections not usually required." this catalog has two ats connectors (p/n (b)(6) and one of them have the cap with damage (p/n (b)(6).A blue connector was put on red connector (with cap damage) without tubings , and was tested on uson leak tester utl-10.The connector failed the test.Wi-pev-016 rev.03.One ats conncetor p/n (b)(6) of finish good s-1102-08lf have the cap p/n (b)(6) with damage.However, it cannot be confirmed that such damage was originated during the manufacturing process.The ats connectors p/n (b)(6) are 100% tested by leaks on uson leak tester utl-10.It was reviewed the process of assembly the tubings , and ats connectors and no issues were found than can lead to the damage observed on cap of sample received from customer.It is unknown in what part of supply chain the component p/n (b)(6) was damaged.Nevertheless, all personnel from the production line will be notified for this issue in order to keep them aware of the issue reported.
Event or Problem Description
Damage to the sample port area out of the package causing system air leak that required additional taping of connections not usually required.The damage was not found prior to connecting to the patient and there was no package damage.The damage and the air leak occurred at the red/blue connectors.

• 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: 14946261
• Report Number: 3004365956-2022-00042
• Device Sequence Number: 4534953
• Product Code: KDQ
• UDI-Device Identifier: 14026704631671
• UDI-Public: 14026704631671
• 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): 06/17/2022

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 Expiration Date: 02/08/2025
• Device Model Number: IPN028485
• Device Catalogue Number: S-1102-08LF
• Device Lot Number: 74B2200791
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/09/2022
• 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
• Patient Sex: Unknown