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

Model Number	ME5303
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint of safety clamp issues could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.No patient harm.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which stated, "carefusion maxguard pressure rated extension set, me5303, lot 15125541 we recently starting using this extension tubing we have had multiple reports of the blue clamp cracking when sliding the clamp into place with normal amount of pressure this renders it ineffective and has also caused leaking onto floor or patient." there was no customer harm.Received a copy of the customer's additional information letter from fda which states, ¿carefusion maxguard pressure rated extension set, me5303, lot 15125541.We recently starting using this extension tubing.We have had multiple reports of the blue clamp cracking when sliding the clamp into place with normal amount of pressure.This renders it ineffective and has also caused leaking onto floor or patient.Manufacturer response for tube - iv/oxygen/pressure/suction (includes iv extension), maxguard pressure rated extension set/me5303 (per site reporter).Manufacturer found that the issue was due to a fault during the manufacturing process.".

• Brand Name: MAXGUARD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9178975
• Report Number: 9616066-2019-02835
• Device Sequence Number: 2763628
• Product Code: FPA
• UDI-Device Identifier: 10885403274435
• UDI-Public: 10885403274435
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 09/16/2019

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: 12/01/2020
• Device Model Number: ME5303
• Device Catalogue Number: ME5303
• Device Lot Number: 15125541
• 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: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1