MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU TERUMO SURSHIELD SAFETY I.V. CATHETER; INTRAVASCULAR CATHETER

Catalog Number SR-SFA2032

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

Udi - the corresponding lot is not subjected for udi; implanted date: device was not implanted; explanted date: device was not explanted; device manufacture date - 11/04/18 ~ 11/07/2018.Initial reporter: (b)(6).(b)(4).The actual device and one unused sample was returned to the manufacturing facility for evaluation.The actual sample was observed visually, a part of the catheter was snapped off approximately 9mm away from its root.Since the snapped catheter alone is measured approximately 22mm long, no missing portion is expected.When closely checked the damaged portion under microscopic observation, the damage was appeared to be squeezed while the damage surface was in both smooth and rough portion.The unused sample was then visually observed.No irregularity that could have attributed physical deformation or scratch on catheter, were observed.The manufacture inspection record was traced back and reviewed.No defective properties catheter snap or scratch to degrade functionally of the catheter were detected.Furthermore, there has been no similar event ever reported by other medical institutions.The reported damage seen on the catheter is presumed to be done by unintentional contact with a sharp object.The damage on the catheter might have been to be stretched afterward and separated as consequence.(b)(4).

Event Description

The user facility reported that upon replacement of a catheter in a patient, the shorten tube was removed from the patient.However, a graphical image of the median vein in the elbow was later verified and a fragment was visually confirmed.The fragment was successfully removed by surgical incision.The current condition of the patient is reported to be fine.

• Brand Name: TERUMO SURSHIELD SAFETY I.V. CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• 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: mark vornheder ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8440320
• MDR Text Key: 139456563
• Report Number: 9681835-2019-00005
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082362
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SR-SFA2032
• Device Lot Number: 181103H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• 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
• Patient Outcome(s): Required Intervention