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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Fluid Leak (1250)
Patient Problem Pain (1994)
Event Date 01/08/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (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 one of the connectors of the filter was broken long after the assembly and device been placed. Because of this there was a leak causing disruption in the anesthesia flow. Clinical consequences: the pain reappeared and the patient was distressed. Procedure delayed and device replaced.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the flat filter with no relevant findings. The customer reported the flat filter broke during use. The customer returned one opened kit (reference files inp1900074818). The flat filter was removed from the kit and was visually examined with and without magnification. Visual examination revealed the male luer slip end of the filter was detached from the filter (reference files anp1900074818). The customer also provided a photo that shows the male luer end missing from the filter (reference files pic 1900074818). A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received. The reported complaint of the filter breaking during use was confirmed based on the sample received. Visual inspection revealed the male luer slip end of the filter was received detached. A device history record review was performed on the flat filter with no relevant findings. It is unknown how the filter was handled prior to and during use. The investigation found no evidence to suggest a manufacturing related cause. Therefore, the potential cause of the filter leaking could not be determined.
 
Event Description
It was reported that one of the connectors of the filter was broken long after the assembly and device been placed. Because of this there was a leak causing disruption in the anesthesia flow. Clinical consequences: the pain reappeared and the patient was distressed. Procedure delayed and device replaced.
 
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Brand NameEPIDURAL CATHETERIZATION SET
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9621671
MDR Text Key180317812
Report Number3006425876-2020-00102
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/10/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19K1979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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