MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	11608375
Medical Device Problem Codes	Break (1069); Failure to Disconnect (2541); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, no patient details: dob, age, gender, weight, or diagnosis were available.(b)(4).The nurse stated that there was no harm to the patient as a result of the stuck tubing or the picc replacement.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that during a dressing and tubing change for a homecare patient, the nurse attempted to remove the tubing from the peripherally inserted central catheter (picc) lumen hub.The tubing was stuck, and in the process of untwisted the device, the tubing snapped, leaving a piece of the plastic male end of the extension tubing inside the picc hub.The nurse was not able to remove the piece of tubing in the hub resulting in a picc line replacement.There was no patient harm as a result of the event or the picc line replacement.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8661071
• Report Number: 9616066-2019-01441
• Device Sequence Number: 13911265
• Product Code: FPA
• UDI-Device Identifier: 10885403273971
• UDI-Public: 10885403273971
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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
• Operator of Device: Health Professional
• Device Model Number: 11608375
• Device Catalogue Number: 11608375
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention