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

Model Number	IPN028442
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Inside sterile wrapping of pleur-evac a-6000-08lf unit had a small tear.Plastic wrapping was intact per contact email.Product unused and contact would like to know what to do with unit.
Event or Problem Description
Inside sterile wrapping of pleur-evac a-6000-08lf unit had a small tear.Plastic wrapping was intact per contact email.Product unused and contact would like to know what to do with unit.
Additional Manufacturer Narrative
Qn #(b)(4).The device history record of batch number 74a2101836 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 & inspected according to our specifications.One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74a2101836 was received for analysis.The wrapped bottle was outside the header bag.It was observed the non-woven tape broken.No issues were observed on csr wrap.The bottle was unwrapped, and it was observed the corner of printed face broken, near to suction port.The missing corner was inside of packaged.In visual inspection it was observed the non-woven tape and the printed face broken.However, such damages cannot be confirmed as manufacturing issue related since there is no sufficient evidence to assure that these issues were originated during the manufacturing assembly.In addition: no damages were reported for lot 74a2101836 when sent for sterilization and distribution center.The device history record of batch number 74a2101836 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 & inspected according to our specifications.One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74a2101836 was received for analysis.The wrapped bottle was outside the header bag.It was observed the non-woven tape broken.No issues were observed on csr wrap.The bottle was unwrapped, and it was observed the corner of printed face broken, near to suction port.The missing corner was inside of packaged.In visual inspection it was observed the non-woven tape and the printed face broken.However, such damages cannot be confirmed as manufacturing issue related since there is no sufficient evidence to assure that these issues were originated during the manufacturing assembly.In addition: no damages were reported for lot 74a2101836 when sent for sterilization and distribution center.

• 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: 12853254
• Report Number: 3004365956-2021-00307
• Device Sequence Number: 4005786
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74A2101836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2021
• 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