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

Model Number	ME5303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/26/2018
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.Although requested, patient demographics not provided.
Event or Problem Description
The customer reported that the slide clamp on the extension set breaks.The broken clamp does not prevent flow, therefore, the nurses continue to infuse with the set.Although requested there was no other information provided.
Additional Manufacturer Narrative
The customer¿s report that the slide clamp breaks was confirmed.The extension set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears.The slide clamp was assembled on the set.A vertical crack was visible at the injection molding gate location, extending completely from the inside clamp opening, confirming the customer¿s report.Tool marks were not observed.No other evidence of damage or anomalies was observed upon visual inspection.Functional testing was not performed as visual inspection confirmed the customer¿s report of a broken slide clamp.The root cause was identified 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.The broken clamp does not prevent flow, therefore, the nurses continue to infuse with the set.Although requested there was no other information provided.
Additional Manufacturer Narrative
Capture event date of (b)(6) 2018- additional information added to: date of event.
Event or Problem Description
The customer reported that the slide clamp on the extension set breaks.The broken clamp does not prevent flow, therefore, the nurses continue to infuse with the set.Although requested there was no other information provided.A copy of the customer's medwatch report was received from the fda stating, "five additional iv extensions sets with broken clamp given to turn over to clinical engineering.Facility continues to have issues with blue slide clamp on extension cracking when used.Additionally, it was reported to me that anesthesiologists are reporting difficulty taping extension tubing in place as the tubing is too rigid this is resulting in tubing getting caught on things and ivs actually or potentially being pulled out.".

• Brand Name: MAXGUARD EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8395232
• Report Number: 9616066-2019-00642
• Device Sequence Number: 2989289
• 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: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2019

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: 02/19/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 07/08/2019; 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1