MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLASH PLUS SAFETY I.V. CATHETER; SURFLASH SAFETY I.V. CATHETER

Catalog Number SR-FVP2225

Device Problem Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number is not required for the reported device.Device manufacturer date - 05/04/2017 thru 05/08/2017.The actual device was not returned for evaluation.Therefore, the investigation was limited to three retention samples from the reported product code/lot number combination.The inner-needle was closely examined by withdrawing it from the catheter in a straight backward motion.As a result, it was confirmed the safety cover was properly able to shield the tip of inner-needle as intended.A review of the manufacturer inspection records was conducted with no findings.Visual inspection conducted after the product assembly also showed no product with defective activation of the safety-cover.Furthermore, there has been no similar incidents ever reported for the concerned lot by other medical institution.The investigation confirmed that the retention samples were the normal product.With no device return, the exact cause of the reported event cannot be definitively determined.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not grasp at the junction of hub and tip of the safety mechanism to disconnect.To assure activation of safety mechanism; withdraw the inner needle with care while avoiding an extreme angle or rotating motion.(b)(4).All available information has been placed on file in quality assurance for tracking, trending, and follow up.

Event Description

The user facility reported that while the inner-needle was being withdrawn after successful catheter placement, a strong sense of resistance was experienced and the safety cover did not activate as intended.There is no known impact to the patient.

• Brand Name: SURFLASH PLUS SAFETY I.V. CATHETER
• Type of Device: SURFLASH SAFETY I.V. 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: 7070042
• MDR Text Key: 93715572
• Report Number: 9681835-2017-00039
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: SR-FVP2225
• Device Lot Number: 170506A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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