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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO AVF TULIP NEEDLE; AVF NEEDLE

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NIPRO (THAILAND) CORP. LTD. NIPRO AVF TULIP NEEDLE; AVF NEEDLE Back to Search Results
Model Number FT+152530BC
Device Problems Unintended Ejection (1234); Leak/Splash (1354)
Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 01/08/2019
Event Type  malfunction  
Manufacturer Narrative
Initial investigation report is on representative samples, final investigation is pending.Customer returned unused samples from product they had in stock, they can not confirm that this is the lot related to the event.Lot number for reported event will remain as unknown and returned samples will be investigated as representative samples.
 
Event Description
Patient arrived to facility for scheduled hemodialysis treatment, alert and oriented.Pre-dialysis vital signs obtained: b/p 184/107; pulse 77; resp 18; temp 97.5.Hemodialysis treatment was initiated at 05:11.At 06:55, the patient stated she has a headache and was lightheaded; patient requested acetaminophen.B/p was 66/38, pulse 69.The dialysis machine alarmed.The right upper arm avf was covered with a blanket and when the blanket was removed, it was noted that the venous bloodline was disconnected from the venous fistula needle line.Estimated blood loss 500-800ml; blood was noted on the floor, blanket, pillow, and patient's shirt.Blood from the extracorporeal circuit was returned to the patient, and 1000ml of normal saline was administered.Oxygen was administered and 911 called.At 07:00, b/p was 73/35; pulse 69.Patient stated she felt better.At 07:09, b/p 121/64, pulse 64.Emergency medical services arrived at 07:10 and transported patient to the hospital.She was observed for several hours then discharged home.The patient returned to her next scheduled dialysis treatment on (b)(6) 2019.Other devices used: fresenius 2008 t dialysis machine; combiset true flow blood tubing; 160 nre optiflux dialyzer; naturalyte acid 2.0k; 2.0 ca; 1.0 mg; 100 dextrose.Other products used: naturalyte 4000 rx12, bicarbonate (45x); fresenius 1000ml normal saline; 3m micropore plus paper tape.
 
Event Description
Patient arrived to facility for scheduled hemodialysis treatment, alert and oriented.Pre-dialysis vital signs obtained: b/p 184/107; pulse 77; resp 18; temp 97.5.Hemodialysis treatment was initiated at 05:11.At 06:55, the patient stated she has a headache and was lightheaded; patient requested acetaminophen.B/p was 66/38, pulse 69.The dialysis machine alarmed.The right upper arm avf was covered with a blanket and when the blanket was removed, it was noted that the venous bloodline was disconnected from the venous fistula needle line.Estimated blood loss 500-800ml; blood was noted on the floor, blanket, pillow, and patient's shirt.Blood from the extracorporeal circuit was returned to the patient, and 1000ml of normal saline was administered.Oxygen was administered and 911 called.At 07:00, b/p was 73/35; pulse 69.Patient stated she felt better.At 07:09, b/p 121/64, pulse 64.Emergency medical services arrived at 07:10 and transported patient to the hospital.She was observed for several hours then discharged home.The patient returned to her next scheduled dialysis treatment on 01/10/19.Other devices used: fresenius 2008 t dialysis machine; combiset true flow blood tubing; 160 nre optiflux dialyzer; naturalyte acid 2.0k; 2.0 ca; 1.0 mg; 100 dextrose.Other products used: naturalyte 4000 rx12, bicarbonate (45x); fresenius 1000ml normal saline; 3m micropore plus paper tape.
 
Manufacturer Narrative
Initial investigation report attached is on representative samples, final investigation is pending.Customer returned unused samples from product they had in stock, they can not confirm that this is the lot related to the event.Lot number for reported event will remain as unknown and returned samples will be investigated as representative samples.
 
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Brand Name
NIPRO AVF TULIP NEEDLE
Type of Device
AVF NEEDLE
Manufacturer (Section D)
NIPRO (THAILAND) CORP. LTD.
10/2 moo 8, bangnomko, sena
ayuthaya,?, 13110
TH  13110
MDR Report Key8345712
MDR Text Key136617703
Report Number8041145-2019-00002
Device Sequence Number1
Product Code MPB
Combination Product (y/n)N
PMA/PMN Number
K071145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Type of Report Initial,Followup
Report Date 02/28/2019
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 Model NumberFT+152530BC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/23/2019
Initial Date FDA Received02/15/2019
Supplement Dates Manufacturer Received01/23/2019
Supplement Dates FDA Received02/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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