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 Pneumothorax (2012); Distress (2329); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).N/a.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 however the chest drain had to be placed on suction as the patient's pneumothorax had increased.The patient status is reported as "stable and discharged home".

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 however the chest drain had to be placed on suction as the patient's pneumothorax had increased.The patient status is reported as "stable and discharged home".

Manufacturer Narrative

(b)(4).The additional information received on 29sep2023 reported that the patient had an underlying condition of oesophagectomy.Customer complaint cannot be confirmed based on the photos provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.If defective sample becomes available at a later date this complaint will be updated as applicable.

• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17835662
• MDR Text Key: 324499475
• Report Number: 3004365956-2023-00065
• 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

• Date FDA Received: 09/28/2023
• 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: 74F2100008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1