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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOCATH PLUS 24GA X 0.75IN; INTRAVASCULAR CATHETER

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ANGIOCATH PLUS 24GA X 0.75IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 382412
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter fax#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that angiocath plus 24ga x 0.75in needle went through the catheter.The following information was provided by the initial reporter: when insertion catheter, it was difficult to advance and was torn.
 
Manufacturer Narrative
H6: investigation summary: one photo and one used sample with open packaging was received by our quality for evaluation.From visual inspection of the photo and sample, the needle was observed to be pierced through the catheter near the catheter tip.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and automatically rejected by the inline tip spear vision inspection system.The needle pierced through catheter could also occur during product application when the product was manipulated or cannula re-insertion to the catheter.As the sample was used, the actual root cause could not be established.The following controls have been put in place to prevent and detect the needle being pierced through catheter from occurring: the vision system camera is not out of focus when capturing the defect by using various metal blocks for different gauges to prevent the vision assembly from dropping under its weight and the catheter is aligned to one side using vacuum to aid the insertion of the cannula thus reducing the likelihood of this nonperformance from occurring.A daily challenge of the vision system is performed, and visual inspection is performed during outgoing inspection.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that angiocath plus 24ga x 0.75in needle went through the catheter.The following information was provided by the initial reporter: when insertion catheter, it was difficult to advance and was torn.
 
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Brand Name
ANGIOCATH PLUS 24GA X 0.75IN
Type of Device
INTRAVASCULAR CATHETER
MDR Report Key12178428
MDR Text Key263581176
Report Number8041187-2021-00595
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number382412
Device Lot Number0051058
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2021
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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