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

Model Number	IPN028484
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74m2000307 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.Dhr shows that the product was assembled and inspected according to our specifications.Manufacture date: 2020-12-03.Expiration date: 2023-12-02.
Event or Problem Description
The incident happened at the thoracic surgery department.There was an abnormal bubbling (not due to the patient).The leak was at the level of the ats red and blue connector.Despite the clamping the bubbling was remaining.To solve the issue we changed the device.
Additional Manufacturer Narrative
(b)(4).The customer returned one s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) and tubing for investigation.During visual inspection, no obvious signs of damages were observed.The tubing was assembled correctly on each end of the ats connectors.The ats connectors were connected properly and no issues were observed that can lead to a leaking issue.The ats connector was disconnected to confirm the assembly of the o-ring and no damages were observed.Signs of use in the form of biological material were observed on the sample.In an attempt to detect the reported defect, the patient tubing with the ats connectors were connected to a source of air (ref-003358) and was submerged under water.No bubbles were detected.The red and blue ats connector was disconnected, re-connected and re-tested but no leaks were observed again.The sample will be sent to nuevo laredo for further investigation.The ifu provided with this product (l02847 rev.01) provides the following instructions to the user: "in the presence of a large air leak air flow through the pleur-evac sahara system may be increased by increasing suction source, without increasing imposed negativity.It is not necessary to change the suction setting on the pleur-evac sahara system." "the patient air leak meter indicates the approximate degree of air leak from the chest cavity.Observe bubbling in the columns of the patient air leak meter.The meter is labeled from low (1) to high (7).The higher the numbered column through which the bubbling occurs, the greater the degree of air leak.The small arm of the patient airleak meter will display tideling with patient respiration if there is a pleural chest tube placement.The markings on the column are for reference only and do not correspond to actual patient negativity." no corrective actions are required since the complaint cannot be confirmed at this time.The sample will be sent to nuevo laredo for further evaluation.The reported complaint of an "air leak at the red/blue connection(ats)" cannot be confirmed at this time.No damages were observed and no leaks were detected upon investigation.A device history record review was performed with no evidence to suggest a manufacturing related cause.The sample will be sent to nuevo laredo for further evaluation.
Event or Problem Description
The incident happened at the thoracic surgery department.There was an abnormal bubbling (not due to the patient).The leak was at the level of the ats red and blue connector.Despite the clamping the bubbling was remaining.To solve the issue we changed the device.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF 6/C
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11585335
• Report Number: 3004365956-2021-00125
• Device Sequence Number: 4182821
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 12/02/2023
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74M2000307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1