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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05500-KM
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2018
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 the user found leakage from the flat filter while in use. The catheter was removed and replaced. There was no patient injury.
 
Manufacturer Narrative
(b)(4). The customer reported the flat filter was leaking during use. The customer returned one snaplock adapter with clip, one flat filter, and one epidural catheter. The components were received connected. The returned components were visually examined with and without magnification. Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies. Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies. Visual examination of the returned catheter revealed that the catheter appears typical but used. Adhesive material can be seen on the outer extrusion and biological material can be seen between the inner coils. No other defects or anomalies were observed. A manual flow test was performed on the returned filter by connecting a laboratory inventory syringe to the luer-slip end of the returned filter and manually injecting water. Water was observed exiting the luer-lock end of the filter. Then a closed snaplock adapter was connected to the luer-lock end while the laboratory inventory syringe was still connected to the luer-slip end. Water was once again injected into the filter. No leak was detected coming from the returned filter. A device history record review was performed on the flat filter with no relevant findings. A corrective action is not required at this time as the complaint could not be confirmed. No functional issues were found with the returned filter. The reported complaint of the filter leaking could not be confirmed based on the sample received. A device history record review was performed on the flat filter with no evidence to suggest a manufacturing related cause. The returned filter passed a manual leak test. There were no functional issues found with the returned filter. Teleflex will continue to monitor and trend related events.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7902949
MDR Text Key121566097
Report Number3006425876-2018-00631
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 company representative,foreig
Type of Report Initial,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberASK-05500-KM
Device Lot Number71F18B2338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2018
Is This a Reprocessed and Reused Single-Use Device? No

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