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

Catalog Number 1SV*25BLS

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2016

Event Type  Injury  

Manufacturer Narrative

Udi - not required for the reported product code/lot number combination.Age - the exact age of the patient is unknown.It was reported that the patient was in their 70's.Device manufacturer date - 02/15/16 thru 02/16/16.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 a retention samples of the reported product code/lot number combination.Visual inspection revealed no defects.The retention sample was evaluated for cannula stiffness and resistance to breakage and the sample was compliant per iso 9626.A review of the manufacturer inspection record 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.See mdr 9681835-2017-00002 & 9681835-2017-00003 for the reported events for the male patient.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of (b)(4) factory of terumo corporation (manufacturer) registration no.9681835.Exemption number (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 a needle break with the involved device.Follow up communication with the user facility reported: (1) we've had three needles break off in patient's skin.Two of them in one (male) patient, and one in another (female) patient.On (b)(6) 2017 the user facility reported the follow additional information regarding the female patient.Woman in her 70's, (b)(6) with arm circumference 19 cm.Also, received the same medication (dilaudid) as the other patients.Line was being removed for scheduled change on (b)(6) 2016.Needle separated from hub.No snap felt or indication that this was a defective product, per nurse.Needle remained in patient's arm and there was no ill effect to the patient.The needle could be felt under the skin.Patient ultimately died of disease process on an unknown date.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional investigation information.Additional testing of the retention sample was conducted.The retention sample was tested for bonding strength of the needle tube and was confirmed to meet manufacturer specification.

• 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: 6348946
• MDR Text Key: 67948942
• Report Number: 9681835-2017-00004
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K771204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1SV*25BLS
• Device Lot Number: 160216S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 02/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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
• Treatment: DILAUDID PAIN MEDS; SV*25BLS - BOTH 2 3/8", AND 2 ¾"; TEGADERM AT SUB-Q SITE
• Patient Outcome(s): Death; Other
• Patient Weight: 54