MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.One catheter was returned for investigation.When we connected a syringe filled with water, then pressed the plunger, leakage was confirmed at the connection between catheter and catheter hub.Upon microscopically checking the leakage portion inverted v-shape damage, which was presumed to have been created by the inner needle while it was being punctured, was observed.The concerned product type is continuously produced by fully automated machine, and an inner needle and a catheter are assembled by one-time operation.If an inner needle contacts to a catheter tube, the inner needle will become exposed outside of the catheter tube, therefore, the automated inspection machine detects such defective product automatically and those are ejected and delivered to the exclusive disposal container.The accuracy and system function are periodically checked to ensure the integrity of our inspection system.When tracing back and reviewed our manufacture inspection records for past six months, defective products, such as a product with an exposed inner needle or scratch on a catheter, were not observed.We have investigated our manufacture inspection records with focusing on the possibility that the inner needle had contacted to the catheter tube during the inner needle and catheter fitting process.However, we were not able to identify the specific root cause.Relevant instructions for use (ifu) reference: "do not attempt to re-insert a partially or a completely withdrawn needle." terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the terumo surflo i.V.Catheter involved was used as an introducer needle for guidewire insertion.After puncture, the user attempted to remove the inner needle and insert a guidewire; however, it was noticed that the guidewire was exposed out of the catheter hub.The user insisted the insertion was performed straightly.The affected product was replaced with a new one.There was no patient injury/medical or surgical intervention required.No blood loss or health hazard was reported.The event occurred intra-operative.

• Brand Name: SURFLO IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; reg. no. 9681835; 1727-1 tsuiji-arai; showa-cho, nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvid; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14985642
• MDR Text Key: 301512983
• Report Number: 9681835-2022-00015
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K891087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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: SR-OT2232C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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