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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET Back to Search Results
Catalog Number JC-05400-B
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2018
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 physician placed the catheter normally. When he wanted to administrate drug, it was impossible to push the syringe contents through. After removal he tried again with the same result as the catheter had no distal hole. There was no patient injury.
 
Manufacturer Narrative
(b)(4). A device history record review could not be performed as a lot number was not provided by the customer. The customer reported they could not inject through the catheter. The customer returned one snaplock assembly 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 assembly revealed that the snaplock appears typical with no observed defects or anomalies. Visual examination of the returned catheter revealed that the catheter appears typical but used. Biological material can be seen between the inner coils. No other defects or anomalies were observed. A functional flow test was performed on the returned sample per amrq- 000017 section 7. 8; rev. 7. The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed. The components were confirmed to be secured by tugging gently. The snaplock adapter was connected to the lab leak tester (c05176) and the pressure was increased to 10 psi to establish flow. Water could be seen immediately exiting the distal end of the catheter. The flow rate was measured at 8. 6ml/min (c05180), which is within the specification of 1ml/min. No blockages were found. The reported complaint of being unable to inject into the catheter could not be confirmed based on the sample received. The device history records were not reviewed as a lot number was not provided by the customer. The returned components passed a functional flow test and met flow rate specifications. There were no functional issues found with the returned sample.
 
Event Description
It was reported that the physician placed the catheter normally. When he wanted to administrate drug, it was impossible to push the syringe contents through. After removal he tried again with the same result as the catheter had no distal hole. There was no patient injury.
 
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Brand NameEPIDURAL CATHETERIZATION SET
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7964945
MDR Text Key123877562
Report Number3006425876-2018-00649
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberJC-05400-B
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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