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

Catalog Number SR-SFA2419

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - the corresponding product type is not subjected for udi.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter: mr./ms.(b)(6).The user facility reported that when the device was removed from the patient, it was temporarily placed in a kidney basin.Because the needle was unshielded by the safety-cover while it was being withdrawn, the sharp tip was fully exposed.It is unconfirmed whether the needle was properly shielded by the cover while it was being withdrawn.The actual sample was returned to the manufacturing facility for evaluation.The actual sample verified that the safety-cover was not being properly shielded tip of inner needle and was loosely stayed on its half way to the tip.The safety-cover was closely examined under microscopic observation and had no findings of irregularities to attribute detachment of any parts, deformation or malfunction of the device.Next, the catheter-hub was prepared which was brought from our retention sample, was placed it onto the actual sample to create original assembly.It was used to simulate and verify the proper shielding, performance of the sample.Inner-needle pulling was conducted repeatedly 10 times.As a result, the safety cover was confirmed to be safely activated to shield the tip of inner-needle.The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "if the safety mechanism fails to activate, carefully dispose the product appropriately", "for certain activation of safety mechanism, be careful not to withdraw the inner needle at an extreme angle or rotating or too quickly.", and "do not touch the safety cover after withdrawal of the inner needle for infection prevention." the manufacture inspection record was traced back and reviewed up to five years, in which duration is equivalent to expiration of the product and reviewed.As a result, no similar event was noted in the record.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that when the terumo surshield safety i.V.Catheter device was removed from the patient, it was temporarily placed in a kidney basin.Because the needle was unshielded by the safety-cover while it was being withdrawn, the sharp tip was fully exposed.It is unconfirmed whether the needle was properly shielded by the cover while it was being withdrawn.

• Brand Name: 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7613391
• MDR Text Key: 112310952
• Report Number: 9681835-2018-00023
• 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
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SR-SFA2419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2018
• 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