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

Catalog Number S-1100-08LF

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that there was leakage of the connection between the pleur-evac and the ringed tube.It happened on 3 devices the same day with the same patient, same intervention.

Manufacturer Narrative

(b)(4).The device history record of the product: s-1100-08lf, batch number: 74l1800962.Has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.No visual and functional inspection can be performed since the defective sample is not available for evaluation.However, as an additional test, in-process visual and functional inspections were performed to 20 production samples of sub assembly 152753 pe ats conn, needleless, tested order number (b)(4); that were taken randomly from assembly line.This subassembly is part of the fg s-1100-08lf related to this customer complaint.During the inspections no issues or discrepancies were found than can lead to the condition reported by the customer.No conclusion can be established at this time based on the lack of defective of sample.It is necessary the physical sample to perform a properly investigation.

Event Description

It was reported that there was leakage of the connection between the pleur-evac and the ringed tube.It happened on 3 devices the same day with the same patient, same intervention.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8726967
• MDR Text Key: 148962217
• Report Number: 3004365956-2019-00185
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74L1800962
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1