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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-05502-FH1
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/19/2019
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 these two epidural kits had broken lidocaine vials inside the kit.
 
Event Description
It was reported that these two epidural kits had broken lidocaine vials inside the kit.
 
Manufacturer Narrative
(b)(4).The reported lot# for this complaint, 23f19d0265, is for kit# ak-05502 and not for the reported kit# of ask-05502-fh1.The bom for a sk-05502-fh1 indicated no ampules are packaged with this kit.Therefore, a device history record review with be performed based on the lot# reported.A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nc to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.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.Based on the information provided, the potential root cause of this issue is design related.A capa was initiated to further investigate this complaint issue.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8859909
MDR Text Key153239238
Report Number1036844-2019-00864
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 health professional,user faci
Type of Report Initial,Followup
Report Date 07/19/2019
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-05502-FH1
Device Lot Number23F19D0265
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/19/2019
Initial Date FDA Received08/05/2019
Supplement Dates Manufacturer Received09/04/2019
Supplement Dates FDA Received09/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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