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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number AK-05502
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 05/14/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The kit has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the product was received with the outer box intact but when they opened the case they saw that the bottles of sodium chloride had broken, spilled, and evaporated on the trays, rendering them unusable.They reported 23f20a0137 as the lot number.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the kit and saline solution ampule with a potentially relevant finding.For material # k-05500-042a (saline 10 ml solution), lot # 23p19l0271, according to incoming inspection records, (b)(4) of (b)(4) ampules were observed to have tips broken off in a batch of 43200.This is outside of the parameter for this defect.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with a potentially relevant finding on the saline solution ampule.However, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
 
Event Description
It was reported that the product was received with the outer box intact but when they opened the case they saw that the bottles of sodium chloride had broken, spilled, and evaporated on the trays, rendering them unusable.They reported 23f20a0137 as the lot number.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10128145
MDR Text Key194322270
Report Number1036844-2020-00162
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 05/14/2020
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 Expiration Date05/31/2021
Device Catalogue NumberAK-05502
Device Lot Number23F20A0137
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/14/2020
Initial Date FDA Received06/08/2020
Supplement Dates Manufacturer Received06/30/2020
Supplement Dates FDA Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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