• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION 3CC SYRINGE WITH NEEDLE FOR VET USE SYRINGE, PISTON

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO PHILIPPINES CORPORATION 3CC SYRINGE WITH NEEDLE FOR VET USE SYRINGE, PISTON Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 06/15/2017
Event Type  malfunction  
Manufacturer Narrative
It was initially reported the additional information was received on june 21, 2017, however, the additional information was received on june 19, 2017.
 
Event Description
Additional information was received on june 19, 2017.
 
Manufacturer Narrative
(b)(4). This report was not associated with a human patient. Although this report is related to a product that is labeled for use in the veterinary market, the product is identical to product that is labeled for human use. Therefore, this report is being submitted as a precautionary measure. The involved device was not returned to the manufacturing facility for evaluation. Therefore, the investigation was based upon the unopened 26 pieces from the same lot, 4 pieces from lot 160518m received, and the evaluation of the user facility information. The received samples were visually inspected for defects that may lead to broken cannula such as weak epoxy, epoxy breakage, damage, deformations, missing components, tilted and bent cannula. No non-conformity was noted on all samples received. The returned samples were also evaluated for cannula stiffness and resistance to breakage. Result showed that the needles are compliant to iso (b)(4) ((b)(4) needle tubing for manufacture of medical devices - requirements and test methods). Retention samples were subjected to visual inspection and revealed no defects. No non-conformity was noted; all samples were confirmed in good condition. There are a series of visual in-process inspection conducted from needle assembly until final packaging to verify and ensure our needles are free of defects affecting product function. Based on our records, there were no non-conformities noted. A review of the device history record of the product code/lot# combination was conducted with no relevant findings. A search of the complaint file did not find any other report with the involved product code/lot# combination. Prior to shipment, qc conducts outgoing visual inspection to check visual defects that affect product function. Functional performance of the product is also confirmed. There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined based on the available information from the user facility and investigation results. Received samples were compliant to iso (b)(4). Thus, it does not break easily when used on normal usage. (b)(4). All available information has been placed on file in quality assurance for appropriate tracking, trending and follow up.
 
Event Description
The user facility reported breakage with the involved device. Follow up communication with the user facility reported: the needles are breaking off before the hub; this has happened with two devices as they were drawing up the vaccine; occurred once as they were using the device on the patient and it broke off inside the animal; and it was reported that the patient is doing fine, they are watching him closely. Additional information on (b)(6) 2017. During pre-surgical injection prior to neuter, with the syringe/needle combo, the steel needle broke off at the hub. It was reported that there was no bending of the needle prior to breaking. They performed an x-ray, and are hoping it makes its way down. The neuter was performed as intended with no issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3CC SYRINGE WITH NEEDLE FOR VET USE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
binan, laguna
RP
Manufacturer (Section G)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
RP
Manufacturer Contact
terry callahan
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6713474
MDR Text Key202862955
Report Number3003902955-2017-00015
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/07/2021
Device Model NumberN/A
Device Catalogue Number100278
Device Lot Number160907M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-