MAUDE Adverse Event Report: UNOMEDICAL/CONVATEC CONTACT DETACH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	23 IN.
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Problem: three different needle portions of contact detach broke off in our daughter.What happened: our type 1 diabetic daughter uses an animas insulin pump, with contact detach, and a dexcom cgm.During the first instance, we noticed blood sugar levels greater than 400 sustained for multiple hours.After multiple attempts to administer insulin and not seeing any change in blood sugar levels, we ended up replacing and reinserting all of the pump stuff.It was then that we discovered that the needle that was inserted in her to deliver insulin had broken off resulting in no or minimal insulin delivery.We contacted her endocrinologist, and animas.Since animas is closing, the representative that we spoke said they were from medtronic.We ended up needing a surgical consult, resulting in the decision to leave the embedded needle until it causes infection.The second instance of the needle breaking happened during a reset of her cgm.She presented with blood sugar levels of over 550 for over 15 hours, from after dinner to when we woke her up in the morning.We again had multiple attempts to bring her blood sugar down, but without the aid of a cgm we assumed that the amount of insulin we gave her would be effective.In the morning when we checked her blood sugar and noticed how high it was, we once again reset and reinserted a new contact detach set, and discovered that another needle had broken off.Our daughter then started vomiting which is an indication of possible diabetic ketoacidosis.We went to the emergency room, where surgery and endocrinology were consulted.An ultrasound was performed confirming a foreign body.We made the decision to switch infusion sets and were given a sample of 4.We once again contacted anima/medtronic, and they said they would send 4 new insertion kits to make up for the ones that were defective.Medtronic never sent those supplies.Additionally, even after reporting two defective needles from the same batch, medtronic gave no indication of a possible faulty batch or the need to recall the batch.Our new mall order prescription of a different infusion device had not yet arrived.Because we never got the new prescription or the replacement sets promised by medtronic, and because our old product wasn't recalled, we ended up needing to use contact detach tubing again.Our daughter requires insulin for survival.It was this or nothing.On saturday (b)(6) my daughter's blood sugar kept rising, and we kept administering insulin to what seemed like no result.My husband again reset and reinserted everything, to once again discover that yet another needle from the same batch of contact detach has broken off.Given the size of the needle, surgery thinks it is best to leave the needles in place unless they cause infection.So my daughter now has three needles lodged in her, from the same batch of defective contact detach, and medtronic is not doing anything to protect the users of this.Because my daughter has a continuous glucose monitor, we were able to avoid a hospital visit two of the three times this happened.However, the one time that the cgm was being reset and therefore not giving us notifications, resulted in a trip to the hospital.My daughter will most likely have three needles stuck in her the rest of her life, we had trips to the hospital, sustained high blood sugars which can cause lifelong complications, not to mention the frustration of not being able to take care of your child.If other type one diabetics use this without a cgm, i'm sure there will be several hospital visits with the possibility of some very severe complications.On (b)(6) 2018 my daughter's endocrinologist and a medtronic representative suggested we report these events to the fda.Each occurrence was reported to anima/medtronic.Faulty product: contact detach from unomedical, 23 in.6mm, ref: 100-905-00, lot: 5179985, exp 2022-03-01.Dates of occurrence: (b)(6) 2018.

• Brand Name: CONTACT DETACH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL/CONVATEC
• MDR Report Key: 7320606
• Report Number: MW5075726
• Device Sequence Number: 13479022
• Product Code: FPA
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 03/05/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 23 IN.
• Device Lot Number: 5179985
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 10 YR
• Patient Weight: 30