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

Catalog Number A-6000-08LF

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.A functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch number 74d2001195 that belong to catalog number a-6000-08lf has been reviewed and no issues or discrepancies were found which could potentially be related 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.The 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.However, material from the production line was verified and no issues were found that can lead this customer complaint.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: interventional radiology performed left thoracentesis to the patient and connected thoracic drainage system.Immediately, leakage of pleural fluid to the floor is observed, right where the red tie that the device is.For this reason, the doctor indicates to close the pigtail and change the drainage system due to the high risk of pneumothorax.

• Brand Name: PE ADULT-PED DRY/ WET LF
• Type of Device: 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 10793023
• MDR Text Key: 214819920
• Report Number: 3004365956-2020-00226
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 10/20/2020

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 Expiration Date: 04/10/2023
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74D2001195
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1