MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SYRINGE WITH NEEDLE; SYRINGE, PISTON

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Age: (b)(6).Ethnicity: patient is a canine.Race: patient is a canine.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: facility manager.Investigation findings: 213 is based upon the evaluation of the retention samples.Based on the results of our investigation, the root cause of the complaint cannot be identified.The actual sample has not been returned for evaluation.However, checking the lot history files and the retention samples did not result in any non-conformities that may contribute to the complaint.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.This was further confirmed when the retention sample did not break after bending it forty times.We have series of visual inspections to check the condition of the product that might lead to the complaint.Prior to shipment, qc also conducts outgoing inspection that includes visual checking such as bent or damaged on the cannula.This complaint is still for further investigation until the receipt of the actual sample.A follow up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo ((b)(6)) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the terumo survet 3cc syringe with a 3 inch needle was used on a (b)(6) great dane.The canine came in for updated vaccines.When the patient was being restrained in standard jugular position, veterinarian inserted syringe into jugular vein.During insertion patient moved neck slightly and the syringe broke off completely from the hub of needle from needle to luer lock portion.The needle is still lodged in the neck.They performed a radiographic view of the cervical spine from his right lateral, the needle was present in the neck from access and c1.Anticipate an mri to locate the needle.The dog was completely on anesthetize.Alcohol was applied to the fur, to give sanitation.The patient was stable.Additional information was received on 29july2021: this issue was related to a broken needle.No mri was performed.Our dvm was able to consult with a boarded veterinary surgeon and we were able to surgically remove the needle with radiographic views.The owner reports that elvis (the dog) is doing great after the procedure and currently has not had any post op complications.

Manufacturer Narrative

This report is being submitted as follow up, no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.H6: investigation findings: 3221 is based, upon the actual sample; h6: investigation conclusion: 4315 is based, upon the actual sample; 4310 is based, upon the evaluation of the retention samples.A syringe contaminated with blood and test tube was received for investigation.Though the actual sample was received, we cannot perform further evaluation, since it is already contaminated with blood.

• Brand Name: TERUMO SYRINGE WITH NEEDLE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• MDR Report Key: 12320946
• MDR Text Key: 266683136
• Report Number: 3003902955-2021-00042
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K023271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

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 Number: N/A
• Device Catalogue Number: 100276
• Device Lot Number: 201217M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANESTHETIZE
• Patient Age: 3 YR
• Patient Weight: 86