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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; BOTTLE, COLLECTION, VACUUM
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TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; BOTTLE, COLLECTION, VACUUM Back to Search Results
Catalog Number S-1100-08LF
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that: involving a patient who was desaturating due to a pleural effusion.A pleur-evac was used on the patient.There was a constant bubbling in the chamber with the blue liquid, there was even foam because of the bubbling.We have excluded the lung by clamping.Despite clamping, the bubbling was still constant.The leak stopped when we forced strongly the red connector into the blue one.
 
Manufacturer Narrative
(b)(4).The device history record of batch number 74l1900092 has been reviewed and no issues or discrepancies were found which could potentially relate 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 & inspected according to our specifications.No corrective action can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determinate the root cause and the corresponding corrective actions.Customer complaint cannot be confirmed based only on the information 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.
 
Event Description
It was reported that: involving a patient who was desaturating due to a pleural effusion.A pleur-evac was used on the patient.There was a constant bubbling in the chamber with the blue liquid, there was even foam because of the bubbling.We have excluded the lung by clamping.Despite clamping, the bubbling was still constant.The leak stopped when we forced strongly the red connector into the blue one.
 
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Brand Name
PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
Type of Device
BOTTLE, COLLECTION, VACUUM
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10153151
MDR Text Key195123254
Report Number3004365956-2020-00125
Device Sequence Number1
Product Code KDQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/04/2022
Device Catalogue NumberS-1100-08LF
Device Lot Number74L1900092
Was Device Available for Evaluation? No
Date Manufacturer Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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