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

Catalog Number SR-SFA2032

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Udi - the corresponding lot is not subjected for udi.Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).Device manufacture date - 12/06/2017 ~ 12/07/2017.The actual sample was returned to the manufacturing facility for evaluation.The sample was closely checked.The safety-cover was not properly shielding a tip of the inner-needle and was being positioned on its way to the tip.The safety-cover portion was examined under microscopic observation and no defective properties were found.Next, prepared was a catheter-hub alone, which was brought from the retention sample, was placed onto the actual obtained sample to create the original assembly.It was used to simulate and verify the proper shielding performance of the sample.Also, conducted was an inner-needle pulling resistance test, which was repeated 10 times.As a result, of verification, the safety-cover was confirmed to be safely activated to shield the tip of the 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" and "for certain activation of safety mechanism, be careful not to withdraw the inner needle at an extreme angle or rotating or too quickly." a review of the manufacturer inspection record for the reported lot was traced back and reviewed with no findings.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 a nurse suffered from needle stick injury shortly after withdrawing the inner-needle in the emergency room.The inner-needle was not properly shielded to activate the safety-cover.The nurse never withdrew the needle at an extreme angle or rotated it, according to the facility.There is no infection to the patient a periodical checkup is scheduled.The patient is currently being monitored.

• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7581951
• MDR Text Key: 110914779
• Report Number: 9681835-2018-00014
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: SR-SFA2032
• Device Lot Number: 171205H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• 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