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 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device history record cannot be performed since the lot number reported 74e2000333 is not valid for product code s-1100-08lf.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that there is a leak at the ats connector.

Manufacturer Narrative

Qn#(b)(4).The device history record of batch number 74f2000333 that belong to catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) has been reviewed and no issues or discrepancies were found which could potentially be related 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 & inspected according to our specifications.A visual inspection of the product involved in the complaint was performed on a sample provided by the customer of product code s-11 00-08lf (pe sahara dry suct/dry seal lf 6/cs).The assembly of the ats connectors was received incompletely since the blue connector is missing.The assembly of the o-ring in the received red connector was found assembled correctly.A functional inspection of the product involved in the complaint could not be conducted since the ats connectors were not received completely, the blue connector is missing on the received sample.Customer complaint cannot be confirmed since received sample was received incompletely, customer complaint description states that "there is a leak at the ats connector." however, the ats connectors were not received completely since the blue connector is missing.The root cause for the condition reported could not be identified.Nuevo laredo facility will continue to track and trend this failure mode.

Event Description

It was reported that there is a leak at the ats connector.

• 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: 11365037
• MDR Text Key: 233891183
• Report Number: 3004365956-2021-00073
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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: INVALID
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1