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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that surflo 22ga x 1" catheter sheath broke off in the patient's vein when removing catheter.The patient was sent home.There was no blood loss.The event occurred intra-procedure.The patient was not injured and there was no direct allegation that the involved device caused or contributed to patient injury and/or need for medical intervention.
Additional Manufacturer Narrative
Lot number: potential lot numbers: 210908sc and 210901sc.Establishment name: (b)(6).Device manufacture date: potential dates: 08 sep 2021 and 01 sep 2021.The actual sample was not available for evaluation hence we cannot provide detailed information on its actual condition.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.As stated in the complaint details, the iv catheter was broken during removal which indicates that the device was used without any problem.The probability of the breakage cannot be confirmed due to limited information that was provided and the actual sample was not available for evaluation.Most likely, the catheter tube was accidentally cut during the removal of the surgical tape where the catheter tube adhered.Verification of retention samples showed no related defects on the catheter tube that would lead to either catheter tube breakage or detached catheter tube from the hub.Moreover, samples passed the catheter tube and catheter hub fitting force test and have higher tensile strength against our specification of >7.845n.Further evaluation of the tensile strength of our catheter tube was conducted through manual pulling and bending test using resistance breakage tester (in reference to the previous catheter breakage complaints).The catheter tube elongated, and an evident dent was observed however, no breakage or holes were noted on the catheter tube.We have 2 stages of visual inspection.The first station covers the overall condition of the product.The second station covers the inspection of the catheter tip and needle tip condition and the distance between the catheter tip and needle heel.Thus, defects on the catheter tube such as scratch, hole, crack, or partial cut can be detected during these processes.The lot history file showed no related nonconformity or any irregularity that could lead to the complaint.Before shipment, qc conducts an outgoing inspection to check the condition of the product.All samples passed.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

• Brand Name: TERUMO SURFLO INTRAVENOUS CATHETER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; biñan, phl ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna, ; RP
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15130606
• Report Number: 3003902955-2022-00025
• Device Sequence Number: 20275250
• Product Code: FOZ
• UDI-Device Identifier: 34806017512270
• UDI-Public: 34806017512270
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: N/A
• Device Catalogue Number: SR-OX2225CA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown