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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-05500-KM
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Patient Involvement (2645)
Event Date 09/10/2019
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 tray was found damaged before use, when the kit was taken out of the shelf in an operation room. Therefore, a new kit was used instead.
 
Event Description
It was reported that the tray was found damaged before use, when the kit was taken out of the shelf in an operation room. Therefore, a new kit was used instead.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the outer tray and kit with no relevant findings. The customer reported the outer tray was found broken before use. The customer returned one sealed. Visual examination of the returned kit revealed the lower left corner of the outer tray is cracked under the flange. The customer also provided photos that show a kit with a crack under the flange of the outer tray. No other defects or anomalies were observed. A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause. Per the manufacturing site, all incoming outer trays are visually inspected for evidence of stress marks prior to packaging as well as each packaged kit is inspected after sealing and prior to being placed into the corrugate container. The reported complaint of the outer tray being damaged was confirmed based on the sample received. Visual inspection of the returned kit revealed the lower left corner had a crack under the flange. A device history record review was performed on the outer tray and kit with no relevant findings. Also, the outer trays are 100% inspected prior to and after packaging. It is unknown how the kit was handled during shipping or prior to use. The investigation found no evidence to suggest a manufacturing related cause. Therefore, the potential cause of the tray having a break could not be determined.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9193593
MDR Text Key166997928
Report Number3006425876-2019-00813
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 foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue NumberASK-05500-KM
Device Lot Number71F19D1529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2019
Is This a Reprocessed and Reused Single-Use Device? No

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