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

Model Number IPN028485

Device Problem Disconnection (1171)

Patient Problems Distress (2329); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use on patient, "connections are not secure between chest drain catheter and the drainage tube.The drainage tube will spontaneously disconnect from the catheter".As a result, the "staff have taped the connections or used cable ties".The issue occurred while the patient was lying in bed.No patient harm or injury.The patient status is reported as "stable and discharged home".

Manufacturer Narrative

(b)(4).The additional information received on 13oct2023 reported that the patient had an oesophagectomy.The disconnected chest tube was re connected to the drainage system.It was observed on the chest x-ray that the size of pneumothorax has increased.Suction was added to the reconnected chest drain.Customer complaint could not be confirmed based on the photos provided, and a sample was not returned to perform an investigation and determine the source of defect reported.An attempt to duplicate the failure mode was made but at the time there was no inventory of the involved product code available at the facility neither was being manufactured at the time.A device history record review was performed, and no relevant findings associated to the complaint report were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that during use on patient, "connections are not secure between chest drain catheter and the drainage tube.The drainage tube will spontaneously disconnect from the catheter".As a result, the "staff have taped the connections or used cable ties".The issue occurred while the patient was lying in bed.No patient harm or injury.The patient status is reported as "stable and discharged home".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17835715
• MDR Text Key: 324500106
• Report Number: 3004365956-2023-00066
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 04026704417469
• UDI-Public: 04026704417469
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN028485
• Device Catalogue Number: S-1102-08LF
• Device Lot Number: 74H2200832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1