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

Model Number	IPN028485
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Big air leak in the red-bleu connector with clamp above connection there is an air leak with clamp below connection there is no air leak, so it is in the connection.
Additional Manufacturer Narrative
(b)(4).A dhr review could not be conducted since the lot number was not provided.A visual inspection of the product involved in the complaint was performed only on the ats connectors received from the customer under customer complaints (b)(4) of product code s-1102-08lf (pe sahara dry suct/dry seal dual lf 6).However, ats connectors provided by the customer were received with the tubing cut.No additional damage was found on the received connectors that can lead to a leaking issue.Also, it was confirmed that the tubing is assembled correctly on each end of the ats connectors.The assembly of the o-ring was verified, and it was found assembled correctly.Functional inspection test cannot be performed since the sample involved in this customer complaint was receive incomplete only the ats connectors were received for evaluation.Received sample was connected to a bottle to simulate the use using water; it was tested with suction and no leakage issues were observed, the sample was connected and disconnected several times to see if any of these disconnections could lead to a leakage issue and no leaks were observed.A visual inspection of the product involved in the complaint was performed only on the ats connectors received from the customer under customer complaints (b)(4) bof product code s-1102-08lf (pe sahara dry suct/dry seal dual lf 6).However, ats connectors provided by the customer were received with the tubing cut.No additional damage was found on the received connectors that can lead to a leaking issue.Also, it was confirmed that the tubing is assembled correctly on each end of the ats connectors.The assembly of the o-ring was verified, and it was found assembled correctly.Received sample was connected to a bottle to simulate the use using water; it was tested with suction and no leakage issues were observed, the sample was connected and disconnected several times to see if any of these disconnections could lead to a leakage issue and no leaks were observed; for testing purpose intentionally, a poorly connection on the ats connection was performed (50% assembled) and not leakage issues were observed, also for testing purpose intentionally the hoses were connected to be inverted way, connecting the blue connector towards the patient's port as the part that has the o-ring is the red ats, trying to have the flow collided with the o-ring, however no leaking issues were observed.Based on the received sample and testing perform to it, customer complaint cannot be confirmed; nuevo laredo facility will continue to track and trend this failure mode.Based on previous statements it is not possible to establish corrective actions.
Event or Problem Description
Big air leak in the red-bleu connector with clamp above connection there is an air leak with clamp below connection there is no air leak, so it is in the connection.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL DUAL LF 6
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11843299
• Report Number: 3004365956-2021-00187
• Device Sequence Number: 11921055
• Product Code: KDQ
• UDI-Device Identifier: 14026704631671
• UDI-Public: 14026704631671
• 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): 05/17/2021

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: IPN028485
• Device Catalogue Number: S-1102-08LF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1