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

Model Number	ME5303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
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.
Event or Problem Description
The customer reported that the slide clamp on the extension set breaks.
Additional Manufacturer Narrative
Correction; h6; patient code.Additional information provided: d.10.The customer¿s report that the slide clamp broke was confirmed.The sets were visually inspected for incomplete engagements, cracks, misassembles or damages to the components.No damages were observed on the slide clamps.Visual inspection of the set noted a vertical crack was visible at the injection molding gate location, extending completely from the inside clamp opening.Functional testing resulted in after priming, the slide clamps were closed and opened.Out of the 14 sets, 2 slide clamps cracked upon attempting to close the clamp.The root cause of the slide clamp extension breaks were identified to be a result of two contributing factors: non-ideal gate location (during injection molding) and shelf life of the slide clamp raw material.

• 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: 8597577
• Report Number: 9616066-2019-01268
• Device Sequence Number: 11349358
• Product Code: FPA
• UDI-Device Identifier: 10885403274435
• UDI-Public: 10885403274435
• Combination Product (Y/N): N
• Initial Reporter Country: MI
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,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: 08/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1