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

Model Number N/A

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Note: 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 9626 (stainless steel 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.The same user facility reported similar events for other devices with the same product code/lot number combination, see mdr's 3003902955-2017-00015 and 3003902955-2017-0017.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 9626.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; and once as they were using the device on the patient and it broke off inside the animal.Additional information on (b)(6) 2017.Two of the needles broke off (steel) all the way down at the hub.It was reported that there was no bending of the needle prior to breaking.It just fell off all the way down at the hub.

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.

• Brand Name: 3CC SYRINGE WITH NEEDLE FOR VET USE
• Type of Device: SYRINGE, 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 Key: 6713517
• MDR Text Key: 80035629
• Report Number: 3003902955-2017-00016
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: N/A
• Device Catalogue Number: 100278
• Device Lot Number: 160907M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1