MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK INFUSION SET; SUBCUTANEOUS INFUSION SET

Lot Number ASKU

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/08/2016

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the united states.While this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

It was reported that the teflon cannula dislodged and remained in the patients stomach area after removing the adhesive of the infusion set.The caller did report that the infusion set was being worn for 4 days.The patient experienced pain and went to his local hospital.The hospital conducted an ultrasound and were able to see the teflon cannula inside the body.The hospital attempted to remove the teflon cannula with a local anesthetic, but were unsuccessful.The patient was sent to surgery under general anesthesia to remove the cannula.During surgery they were unable to locate the teflon cannula, which could be seen with the ultrasound.Caller advised they removed fat, trying to locate the cannula, but were still unable to locate it and remove it.The patient was discharged from the hospital.It is unknown how long the patient was hospitalized.To date patient believes that the cannula piece is still inserted into his stomach area, but has no pain associated with it.The lot number was not provided.The infusion set was discarded; therefore, no product could be requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® FLEXLINK INFUSION SET
• Type of Device: SUBCUTANEOUS INFUSION SET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): UNOMEDICAL DEVICES S.A. DE C.V; avenida fomento industrial lot; parque industrial del norte; reynosa C.P. 8873; MX C.P. 88736
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7556517
• MDR Text Key: 109633124
• Report Number: 3011393376-2018-02219
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73