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

Model Number	ME5303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that the slide clamp on the extension set breaks.
Additional Manufacturer Narrative
The customer¿s report that the slide clamp broke was not confirmed.Received from the customer were 30 new, unused extension sets model me5303, lot 15125541.Visual inspection of the set noted no damage or any anomalies.Functional testing consisted of priming the tubing, after which the slide clamps were closed and opened.No anomalies were observed.The customer¿s report that the slide clamp breaks was not confirmed.The root cause was not definitively identified.Previous investigations identified the root cause of this issue to be a result of two contributing factors: non-ideal gate location and shelf life of the slide clamp raw material.
Event or Problem Description
The customer reported that the slide clamp on the extension set breaks.
Additional Manufacturer Narrative
Additional medwatch information provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "product 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." an incomplete date of event of (b)(6) 2018 was provided.

• Brand Name: PRESSURE RATED EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8587961
• Report Number: 9616066-2019-01237
• Device Sequence Number: 1587383
• 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: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 09/16/2019; 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1