MAUDE Adverse Event Report: CAREFUSION MINIBORE PRESSURE RATED EXT, IV CNNCTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MZ5301
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Per customer, they are not allowed to provide any patient demographics.
Event or Problem Description
Multiple disposable products (received attached to each other) were returned unexpectedly, and it was reported that majority of the products have the same reoccurring issue of breaking, cracking or leaks.Although requested, additional information was not provided.
Event or Problem Description
Multiple disposable products (received attached to each other) were returned unexpectedly, and it was reported that majority of the products have the same reoccurring issue of breaking, cracking or leaks.Although requested, additional information was not provided.
Additional Manufacturer Narrative
The customer¿s report that the majority of the products have the same reoccurring issue of breaking, cracking or leaks was not confirmed.The sets and maxzero connectors were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in the set flowing freely and ran with no issues or leaks.Dimensional analysis was performed on the male and female luer ends of the maxzero connectors as well as all the male and female luers on each set and were found to be within the required specifications.The root cause of the customer¿s reported reoccurring issue of breaking, cracking or leaks was not identified.The device history record for minibore extension set model mz5301 lot number unknown could not be conducted because the lot information was not provided.

• Brand Name: MINIBORE PRESSURE RATED EXT, IV CNNCTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9964632
• Report Number: 9616066-2020-01327
• Device Sequence Number: 2740616
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: 10885403230547
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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 Model Number: MZ5301
• Device Catalogue Number: MZ5301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-BD BIFUSE, (2)NON-BD EXT, TD UNK