MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURFLO INTRAVENOUS CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Material Puncture/Hole (1504); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - vet application.Age & date of birth - vet application.Patient sex - vet application.Weight - vet application.Ethnicity - vet application.Race - vet application.Udi - not applicable.Operator of device - unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Reporter occupation - shift lead.Investigation findings - (b)(4) is based upon the evaluation of the sample; (b)(4) is based upon the evaluation the retention samples.Two pieces of the sr iv catheter was returned for evaluation.The received samples were visually inspected.The samples were placed inside a container and it was noted to have traces of blood.The catheter tubes of both samples were observed to be damaged.The actual samples were further verified under high magnification.The 1st sample was noted to have needle sticking out of the catheter tube.A hole was observed on the punctured part of the catheter tube.In addition, the tip of the catheter tubes was found to be kink for both samples.Based from the results of our investigation, the root cause of the problem was possibly during usage wherein reinsertion happened that lead to damage on catheter tube.Verification of retention samples showed no defects found such as scratch, cracks, bent or any defects that may contribute to the complaint.The catheter tube is made up of (b)(4) material which has high tensile strength and does not break easily even when a strong force is applied.Also, it assures smooth vein puncture with minimum penetration resistance for lessened pain.Our products have undergone series of inspection and verification.Defects such as broken catheter tube can be easily detected thru our process.Production runs under validated parameters.Lot history file showed no non conformity was reported during production of this lot.Moreover, qc conducts visual, sensory and functional inspection to check product quality prior shipment.No nonconformity related to the complaint noted.Thus, the lot was shipped in good condition.This report was reassessed during an internal audit and deemed reportable based upon the device malfunction could potentially result in iv catheter breakage of the distal end and/or retention in patients if to recur.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo ((b)(4)) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported the catheter was burring and poking through the plastic.They removed all they had from inventory.The total was 62 units including 3 that were used and 59 in inventory.Additional information was received on 17august2017: it was confirmed that the burring was happening after the catheter was is in the vein and they would try threading off (it catches and doesn't go forward).They would also try to thread the catheter back on to the needle and reposition or they would have to start over with a new iv catheter.He said they expect burring to occur every now and then, but it has been happening much more.

• Brand Name: TERUMO SURFLO INTRAVENOUS CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12159236
• MDR Text Key: 267098649
• Report Number: 3003902955-2021-00028
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: SROX2225V
• Device Lot Number: 161127SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2016
• 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