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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO SAFETOUCH II AVF NEEDLE

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NIPRO (THAILAND) CORP. LTD. NIPRO SAFETOUCH II AVF NEEDLE Back to Search Results
Model Number FS+152530BC
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  malfunction  
Event Description
During dialysis treatment the small clear plastic ring below the safety, had cracked and fell off. Treatment was completed and the nurse went to remove the avf fistula needle and noted it was sitting by the patients hand. No issue removing the avf needle. No injuries or medical interventions reported.
 
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Brand NameNIPRO SAFETOUCH II AVF NEEDLE
Type of DeviceAVF NEEDLE
Manufacturer (Section D)
NIPRO (THAILAND) CORP. LTD.
10/2 moo 8
bangnomko,
sena, ayuthaya 13110 ,
TH 13110,
Manufacturer (Section G)
NIPRO (THAILAND) CORP. LTD.
10/2 moo 8
bangnomko,
sena, ayuthaya 13110 ,
TH 13110,
Manufacturer Contact
michelle tejada
3150 nw 107th avenue
miami, FL 33172
3055997174
MDR Report Key11897875
MDR Text Key266940077
Report Number8041145-2021-00013
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K032777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFS+152530BC
Device Catalogue NumberFS+152530BC
Device Lot Number20D16
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/27/2021 Patient Sequence Number: 1
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