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 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A video is available for analysis.It was observed the two patient tubes clamped with a medical instrument, the orange float in suction indicator window and a bubbling in air leak meter.Also, it was observed fluids in collections chamber.No other issues were observed.The device history record of batch number 74f2000341 that belong to catalog number s-1102-08lf (pe sahara dry suct/dry seal dual lf 6) 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 and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.If the defective sample becomes available at later date this complaint will be updated as applicable.

Event Description

It was reported that after surgery the patient was connected to the drainage - non drainage function.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL DUAL LF 6
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 11546086
• MDR Text Key: 243810779
• Report Number: 3004365956-2021-00101
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 14026704631671
• UDI-Public: 14026704631671
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Model Number: IPN028485
• Device Catalogue Number: S-1102-08LF
• Device Lot Number: 74F2000341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1