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

Catalog Number SR-FF2225

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Unspecified Infection (1930); Swelling (2091); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Ethnicity - patient involved was a canine.Race - patient involved was a canine.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon the user facility information and the evaluation of five retention samples from the reported lot.The retention samples were evaluated by microscopic investigation, and no defective properties were found.All samples were compliant per iso 10993.The user facility reported similar events from the same product code/lot number combination.See mdrs 9681835-2018-00005, 9681835-2018-00006, and 9681835-2018-00007.A review of the manufacturer inspection record for the reported lot was conducted with no findings.The evaluation of the actual device could not be conducted due to the device not being returned.(b)(4).

Event Description

The user facility reported that a customer contacted distributer to report that they "have been experiencing vein blow which then is causing infections with swelling and fever with the 22x1 surflash catheter".The patient involved is a dog.The procedure outcome was cleared and the patient did recovered.It was reported that the estimated blood loss was <250cc.

• Brand Name: SURFLASH I.V. CATHETER
• Type of Device: SURFLASH 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: 7235294
• MDR Text Key: 99195509
• Report Number: 9681835-2018-00008
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SR-FF2225
• Device Lot Number: 161604D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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