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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO SYRINGE WITH NEEDLE

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NIPRO (THAILAND) CORP. LTD. NIPRO SYRINGE WITH NEEDLE Back to Search Results
Model Number JD+01T2516
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/22/2015
Event Type  Injury  
Event Description
A (b)(6) month old domestic cat with a grade 2 heart murmur was undergoing a neutering procedure. (the vet did not want the cat under anesthesia longer than necessary due to the heart murmur) during the procedure the vet administered pre medication intramuscular using the syringe with needle. While attempting to remove the needle, it broke off and was remained stuck inside of the cat's left leg. An x-ray was taken to confirm the needle's location. An incision was made over the area where the needle was stuck and extracted with a hemostat. One skin suture was placed to close the incision. The cat was under anesthesia for longer than expected due to the incident and also received additional pain medications and antibiotics. A follow up appointment was schedule for 2 weeks from incident date and for suture removal.
 
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Brand NameNIPRO SYRINGE WITH NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
Manufacturer (Section D)
NIPRO (THAILAND) CORP. LTD.
10/2 moo 8, bangnomko, sena
ayuthaya,, 13110
TH 13110
MDR Report Key10026852
MDR Text Key189970989
Report Number1056186-2015-00018
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Model NumberJD+01T2516
Device Lot Number15B09
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2015
Distributor Facility Aware Date06/23/2015
Event Location Outpatient Treatment Facility
Date Report to Manufacturer06/23/2015
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/05/2020 Patient Sequence Number: 1
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