MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO WINGED INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 1SV*23BLS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Skin Inflammation (2443)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned to the manufacturing facility for evaluation.Therefore the investigation results are based upon the user facility information and the evaluation of the retention samples from the reported product code/lot# combination.Visual inspection revealed no defects.The following series of biocompatibility tests have be conducted in accordance with iso10993: intradermal reaction, acute toxicity, heat buildup, hemolytic, cytotoxicity and sensitizing property meeting specification.A review of the manufacturing and inspection records was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined.(b)(4).All available information has been placed on file in quality assurance for tracking, trending, and follow up.Device not returned to manufacturer.

Event Description

The user facility reported that three patients out of fifteen had reactions such as edema, redness and heat when using the surflo winged infusion set used for subcutaneous administration of morphine.One patient has developed a cellulite, requiring antibiotic treatment.Maintained the same winged infusion set installed for a period up to 3 days.Normal technique for this facility.Follow up communication with the user facility on 4/26/2016 reported: the event occurred on (b)(6) 2016.The winged infusion set was installed on (b)(6) for haldol sub-cutaneous admin then changed on (b)(6) due to induration, redness, this event occurred again on (b)(6) and changed the infusion set again; patient has a diagnosis of van recklinghaunsen (fibrothemathome) disease.Context of palliative care.When using new winged infusion sets from terumo, appearance of redness, heat, edema at the insertion site; it was reported the patient developed a cellulitis requiring the use of an antibiotic for 10 days.Have not had to use other winged infusion sets since the event.The user facility reported similar events for other devices with the same product code/lot# combination, see mdr's 9681835-2016-00011, 968185-2016-00012 and 9681835-2016-00016.See mdr no.9681835-2016-00016 for the report related to the second device used on the patient.

Manufacturer Narrative

This report is being submitted as follow-up # 1 to provide the evaluation results of the eight returned unused samples.The actual device was not returned to the manufacturing facility, however eight unused samples of the reported product/lot number combination was returned for evaluation.Microscopic inspection of the needle of the returned eight unused samples revealed no defects.

• Brand Name: SURFLO WINGED INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 583; JA 409-3583
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; reg. no. 9681835; 1727-1, tsuiji-arai, showa-cho; nakakoma-gun, yamanashi 409-3 583; JA 409-3583
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5641400
• MDR Text Key: 44786416
• Report Number: 9681835-2016-00010
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K771204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 1SV*23BLS
• Device Lot Number: 150803S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2015
• 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
• Patient Age: 66 YR
• Patient Weight: 40