TERUMO CORPORATION - KOFU SURFLO WINGED INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 1SV*23BLS |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Edema (1820); Skin Inflammation (2443)
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Event Date 02/20/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Udi - not required until 09/2016.The actual device was not returned to the manufacturing facility, however eight unused samples of the reported product/lot number combination were returned for evaluation.Therefore the investigation results are based upon the user facility information, eight unused samples and the evaluation of the retention samples from the reported product code/lot# combination.Microscopic inspection of the needle of the returned eight unused samples and the retention samples 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.
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Event Description
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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 cellulitis, 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 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 9681835-2016-00010, 968185-2016-00011 and 9681835-2016-00012.See mdr no.9681835-2016-00010 for the report related to the first device used on the patient.
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