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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 HS-05501
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 03/27/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the corners of the trays are cracking, creating a potential sterility issue.One tray was discovered after opening for a procedure and subsequent inventory was checked.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the outer tray and kit with a potentially relevant finding.Per nc70019082, during incoming inspection for outer tray t-05600-100b (lot#23p19a0261), a white powder residue observed on some of the trays.A rework was performed to remove the residue and the trays were re-inspected and accepted.This is not relevant to this complaint.The customer reported the outer tray of the kit cracking potentially causing sterility issues.The customer returned one opened.Visual examination of the returned kit revealed the lower left and right corners of the outer tray are stressed and cracked under the flange.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.Also, packaging and engineering personnel attempted to duplicate opening sealed kits but concluded significant manual force is needed to crack one or more of the corners of the kit.The reported complaint of the tray is cracking was confirmed based on the sample received.Visual inspection of the returned kit revealed the lower left and right corner showed signs of stress and the lower right 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's corners being stressed , and cracking could not be determined.
 
Event Description
It was reported that the corners of the trays are cracking, creating a potential sterility issue.One tray was discovered after opening for a procedure and subsequent inventory was checked.
 
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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 Key8519452
MDR Text Key142110102
Report Number1036844-2019-00412
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 company representative,health
Type of Report Initial,Followup
Report Date 03/28/2019
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 Expiration Date04/30/2020
Device Catalogue NumberHS-05501
Device Lot Number23F19A0471
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2019
Initial Date Manufacturer Received 03/28/2019
Initial Date FDA Received04/16/2019
Supplement Dates Manufacturer Received05/16/2019
Supplement Dates FDA Received05/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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