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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA Back to Search Results
Catalog Number ASK-05500-JHH1
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2020
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
The patient was admitted to labor and delivery. An epidural catheter was being placed in preparation for a planned c-section. The tough needle was placed. Upon attempting to thread the catheter, at approximately 2 cm into the tough needle, resistance was felt. Re-threading of catheter was attempted, but was unsuccessful when resistance was again felt at 2 cm. Upon removing the catheter from the needle, approximately 5mm of circular metal fragments were noted. The fragments looked similar to circular pencil sharpener shavings, but were naturally much smaller. A new epidural catheter kit was opened, and the epidural was easily inserted. The tip of the original tough introducer needle was intact, as was the catheter they attempted to thread. Since the team was not certain whether any metal fragments had been pushed into the patient and retained under the skin, they obtained an x-ray following delivery, with the consent of the patient, to ensure no metal fragments were present.
 
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Brand NameEPIDURAL CATHETERIZATION KIT: 19 GA
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10719406
MDR Text Key214800670
Report Number1036844-2020-00260
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 health professional
Type of Report Initial,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberASK-05500-JHH1
Device Lot Number23F20D0344
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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