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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35; CATHETER, CONDUCTION, ANESTHET
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA X 35; CATHETER, CONDUCTION, ANESTHET Back to Search Results
Catalog Number ASK-05503-BWB
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Reported issue: customer noted they have had some issues with the luer lock glass syringes related to product quality.The threads on a few have been bent making it difficult/impossible to screw on to the tuohy needle.They have also had issues with leakage at the connection point, also consistent with the threads not lining up.
 
Event Description
Reported issue: customer noted they have had some issues with the luer lock glass syringes related to product quality.The threads on a few have been bent making it difficult/impossible to screw on to the tuohy needle.They have also had issues with leakage at the connection point, also consistent with the threads not lining up.
 
Event Description
Reported issue: customer noted they have had some issues with the luer lock glass syringes related to product quality.The threads on a few have been bent making it difficult/impossible to screw on to the tuohy needle.They have also had issues with leakage at the connection point, also consistent with the threads not lining up.
 
Manufacturer Narrative
(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the lor syringe with no relevant findings.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 without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT: 19 GA X 35
Type of Device
CATHETER, CONDUCTION, ANESTHET
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10792407
MDR Text Key214786963
Report Number1036844-2020-00282
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASK-05503-BWB
Device Lot NumberUNAVAILABL
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received11/05/2020
Supplement Dates Manufacturer Received12/04/2020
Supplement Dates FDA Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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