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

Model Number IPN028442

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number 74e2001203 that belong to catalog number a-6000-08lf (pe adult-ped dry/ wet lf) 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 device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Happened on (b)(6) 2021.There was a leak at the level of the red and bleu connector.The risk for the patient is a pneumothorax.

Manufacturer Narrative

Qn# (b)(4).The customer returned one photo of the product lidstock; reference (b)(4).The complaint of a leak at the red and blue ats connection could not be confirmed by the photo.The customer returned one a-6000-08lf (pe adult-ped dry/wet lf) and tubing for investigation.During visual inspection, no obvious signs of damages were observed.The tubing was assembled correctly on each end of the ats connectors.The ats connectors were connected properly and no issues were observed that can lead to a leaking issue.The ats connector was disconnected to confirm the assembly of the o-ring and no damages were observed.Signs of use in the form of biological material were observed on the sample.In an attempt to detect the reported defect, the patient tubing with the ats connectors were connected to a source of air and were submerged under water to look for leaks.No bubbles were detected.The complaint cannot be confirmed.The ifu provided with this product (l06176 rev.00) provides the following instructions to the user: "in the presence of a large patient air leak, air flow through the pleur-evac unit may be increased by increasing source suction.This will not increase suction imposed on the patient.It is not necessary to change the suction setting on the pleur-evac unit to increase air flow." "the patient air leak meter indicates the approximate degree of air leak from the chest cavity.Observe bubbling in the columns of the patient air leak meter.The meter is labeled from low (1) to high (7).The higher the numbered column through which the bubbling occurs, the greater the degree of air leak." corrective action is not required at this time as no problem was found on the returned sample.The complaint of a leaking ats connection was not able to be confirmed by a complaint investigation of the returned sample.The connection passed all visual and functional testing.No leaks were detected.A device history record review did not reveal and manufacturing issues.Based on the sample returned, no problem was found with the device.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Happened on (b)(6) 2021.There was a leak at the level of the red and bleu connector.The risk for the patient is a pneumothorax.

• Brand Name: PE ADULT-PED DRY/ WET LF
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12217489
• MDR Text Key: 263189508
• Report Number: 3004365956-2021-00238
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2023
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74E2001203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1