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

Model Number IPN028484

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.A device history review could not be conducted since the lot number provided is not a valid lot number.Teleflex will continue to monitor and trend related events.

Event Description

There was direct an air-leak with noise.When pushing hard on the connector it is solved.A new sahara with the same lot number was ok.

Event Description

There was direct an air-leak with noise.When pushing hard on the connector it is solved.A new sahara with the same lot number was ok.

Manufacturer Narrative

(b)(4).A dhr review could not be conducted since the lot number provided is not a valid lot number.Air source (tfm-0060 nlc09684 due date 22-mar-22) was adapted and connected to section of sample received and ats connector was immerse into the water.No bubbles were observed, therefore the ats does not have leaks.Customer complaint cannot be confirmed.No problem found on sample.

• 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: 11581062
• MDR Text Key: 243129359
• Report Number: 3004365956-2021-00107
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74G200134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1