MAUDE Adverse Event Report: CAREFUSION/BD INFUSION SET

Model Number	10013361T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Defective infusion set.This event involves hospitalized inpatient receiving continuous infusion doxorubicin chemotherapy.Patient called nurse to report "tubing popped out when i turned to the side".Patient quickly reattached tubing and no evidence of chemo spill.Rn disconnected and saved tubing for pharmacy to inspect.The infusion set was bd 10013361t; lot #15095909.The flexible plastic tubing had disconnected from the confirming separation due to insufficient bonding solvent; a problem in the manufacturing process.I asked if this was lot related and if there was any recall of the product.Response from bd was no recall and corrective action plan in place to resolve the issue.Second issue with infusion sets at same connection spot on different patient prompted this reporting to fda.Will file separate report for second incidence.

• Brand Name: INFUSION SET
• Common Device Name: INFUSION SET
• Manufacturer (Section D): CAREFUSION/BD; san diego CA
• MDR Report Key: 6600856
• Report Number: MW5070084
• Device Sequence Number: 628020
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: (01)10885403223204
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 10013361T
• Device Lot Number: 15195909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 84