MAUDE Adverse Event Report: CAREFUSION SD 112 IN 15 DROP IV ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9128
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 112 in 15 drop iv administration set came apart.The following information was provided by the initial reporter: material no: (b)(4), batch no: 19127048.It was reported that bd maxguard 15 drop administration set with 3 needleless y-sites came apart very easy while hooked up to the patient.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of tubing coming apart very easy could not be verified due to the product not being returned for failure investigation.A device history record review for model mx9128 lot number 19127048 was performed.The search showed that a total of 3,600 units in 1 lot number was built on 27dec2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that 112 in 15 drop iv administration set came apart.The following information was provided by the initial reporter: material no: mx9128 batch no: 19127048.It was reported that bd maxguard 15 drop administration set with 3 needleless y-sites came apart very easy while hooked up to the patient.

• Brand Name: 112 IN 15 DROP IV ADMINISTRATION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10575232
• Report Number: 9616066-2020-02788
• Device Sequence Number: 2992901
• Product Code: FPA
• UDI-Device Identifier: 10885403237621
• UDI-Public: 10885403237621
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: Other
• Device Expiration Date: 12/27/2024
• Device Model Number: MX9128
• Device Catalogue Number: MX9128
• Device Lot Number: 19127048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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: Other