MAUDE Adverse Event Report: TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; BOTTLE, COLLECTION, VACUUM

Catalog Number S-1100-08LF

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number 74f2000333 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 and inspected according to our specifications.

Event Description

There is a air leak at the level of the connection between the tubing and the pleur evac.Consequence: continuous bubbling that could led the staff think it was because of a parenchymal leak whereas it was not.

Event Description

There is a air leak at the level of the connection between the tubing and the pleur evac.Consequence: continuous bubbling that could led the staff think it was because of a parenchymal leak whereas it was not.

Manufacturer Narrative

(b)(4).One unit of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) lot 74f2000333 was received for analysis.Sample wasn't received in its original packaging and the red part of ats connector (tfx-000460)wasn't received.A functional inspection to confirm the issue reported can not be perform since the red part of ats connector (tfx-000460) wasn't received.Functional test could not be conducted since the complete ats connector was not provided.Customer complaint cannot be confirmed due the lack complete sample to perform a proper investigation and determine the root cause.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11378941
• MDR Text Key: 233539782
• Report Number: 3004365956-2021-00072
• Device Sequence Number: 1
• Product Code: KDQ
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74F2000333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A,