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 01/14/2017

Event Type  malfunction  

Manufacturer Narrative

Udi - the lot number is unknown for the product code reported.Age - the exact age of the patient is unknown.It was reported that the patient was in their (b)(6).The product lot number is unknown and the following are potential lots/manufacturer date/expiration dates: 160216s/02-15-2016 thur 02-16-2016/january 31, 2019; 160307s/03-07-2016 thur 03-08-2016/february 28, 2019 ;160404s/04-04-2016 thur 04-05-2016/march 31, 2019.The actual sample was not returned to the manufacturing facility for evaluation and the lot number is unknown.Therefore, the investigation was based upon the user facility information and the evaluation of retentions samples of the above stated potential lot numbers.Visual inspection revealed no defects.Retention samples were evaluated for cannula stiffness and resistance to breakage and all samples were compliant per iso 9626.The actual device was not returned to the manufacturing facility for evaluation.Therefore the investigation was based on the user facility information and functional testing of five retention samples of the reported product code.Functional testing could not reproduce the reported failure.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 9681835-2017-00003 for the second event reported for the same male patient.See mdr 9681835-2017-00004 for the event reported pertaining to the female patient.(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: we've had three needles break off in patient's skin.Two of them in one (male) patient, and one in another (female) patient; male patient: a sub-q line (sv*25bls) was established and anchored with tegaderm on (b)(6) 2017 in left arm, delivering "dilaudid" pain medication intermittently; the patient was restless; on (b)(6) 2017 during removal of left arm sub-q, the needle was broken completely off; the patient was sent to the er to locate the needle, but refused further treatment because "it was not bothering him"; on (b)(6) 2017 established two sites, one in each arm to continue delivering dilaudid, again patient continued to be restless during care; on (b)(6) 2017 each sub-q line (sv*25bls) was removed per schedule, and found one broken off completely in the right arm, and one was bent in the left arm; the patient was seen in interventional radiology on (b)(6) 2017 and they were unable to remove either needle; the procedure was started, but the patient did not tolerate the positioning; the needles remain in his arms.Additional information was provided from the user facility on 2/3/2017: "the needles are still imbedded in him.He was examined by our nurse practitioner today and they are not palpable.They do not seem to bother him, there is no sign or symptom of infection.Patient's condition is declining unrelated to the needles.".

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the returned sample evaluation results.(b)(4).The actual sample and 11 unused samples were returned to the manufacturing facility for evaluation.Visual inspection of the actual sample revealed that several sections of the needle were damaged.The needle was observed to be ruptured at 2.5 mm away from the wing and the ruptured portion was bent 20 degrees in the downward position.The cross section of the damage was found to be slightly deformed elliptically.No other anomalies were observed.The 11 unused samples were evaluated for cannula stiffness and resistance to breakage and all samples were compliant per iso 9626.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined.Based on the investigation it is likely that the actual device was subjected to excess force causing the reported rupture.

• 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: 6348932
• MDR Text Key: 67949001
• Report Number: 9681835-2017-00002
• 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

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1SV*25BLS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other