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

Model Number	IPN028484
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11581062
• Report Number: 3004365956-2021-00107
• Device Sequence Number: 14498798
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1