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

Model Number	IPN028485
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Distress (2329); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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".
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004365956-2023-00066
• Device Sequence Number: 12614741
• Product Code: KDQ
• UDI-Device Identifier: 04026704417469
• UDI-Public: 04026704417469
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown