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

Model Number IPN028442

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

During the decortication + pleurectomy procedure, thoracic drainage, pleur-evac, is placed and connected to the patient's tube, at which time it is identified that the hose is broken in the red connection , the connection closest to the pleur-evac.The device is changed and attention is continued with suction without problems.

Event Description

During the decortication + pleurectomy procedure, thoracic drainage, pleur-evac, is placed and connected to the patient's tube, at which time it is identified that the hose is broken in the red connection , the connection closest to the pleur-evac.The device is changed and attention is continued with suction without problems.

Manufacturer Narrative

Qn#(b)(4).The device history record of batch number 74a2200234 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: 2022-01-11.Expiration date: 2025-01-10.No corrective action can be established at this moment since the product sample is not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.

Manufacturer Narrative

(b)(4).The device history record of batch number 74a2200234 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.Manufacture date: 2022-01-11.Expiration date: 2025-01-10.One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74a2200234 was received for analysis.Sample wasn't received in its original packaging.It was observed that one corner near to air leak meter is broken.The ats connector pn 152753 was inspected , and no broken issues were observed.After functional test the ats o-ring p/n 154589 was inspected , and no damage issues were observed.The ats connector and tubing were removed form unit, one side of tubing was applied air pressure (10 psi, the other side was clamped and ats connector was immerse into the water.No bubbles were observed that can confirmed a leak on connectors.Equipment tfm-0060.Nlc09684 due date 22-sep-23.Customer complaint cannot be confirmed based on the sample provided.The unit has a broken corner near to air leak meter.However, no leaks were observed , nor it can confirmed that such damage was originated during the manufacturing process.No issues were observed on ats connector p/n 152753 ("connection-red/blue") related with broken nor leak.

Event Description

During the decortication + pleurectomy procedure, thoracic drainage, pleur-evac, is placed and connected to the patient's tube, at which time it is identified that the hose is broken in the red connection , the connection closest to the pleur-evac.The device is changed and attention is continued with suction without problems.

• Brand Name: PE ADULT-PED DRY/ WET LF 6/CS
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15146848
• MDR Text Key: 304450706
• Report Number: 3011137372-2022-00146
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K905768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2022

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
• Device Operator: Health Professional
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74A2200234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/04/2022; 09/05/2022
• Supplement Dates FDA Received: 08/26/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.
• Patient Age: 25 YR
• Patient Sex: Male