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

Model Number IPN028485

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Air leak in the red-blue 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.

Manufacturer Narrative

Qn#(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 on only the ats connectors received from the customer under customer complaints 1900083693 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 at the base of the connectors as opposed to the requested 6 inches of tubing on both sides of the connector.No additional damage was found on the received sample 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 on only ats connectors received from the customer under customer complaints 1900083693 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 at the base of the connectors as opposed to the requested 6 inches of tubing on both sides of the connector.No additional damage was found on the received sample 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.(see attached pictures) 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.Based on sample received 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 Description

Air leak in the red-blue 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
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11665536
• MDR Text Key: 245391836
• Report Number: 3004365956-2021-00122
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 14026704631671
• UDI-Public: 14026704631671
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 04/27/2021
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1