MAUDE Adverse Event Report: CAREFUSION ALARIS SYRINGE ADAPTER SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10010483
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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.Patient is pediatric.Although requested, further information was not provided.
Event or Problem Description
The customer received the iv tubing set from staff with no information, and reported that there was an unspecified iv tubing set issue.When the product was received, it was noted that the tubing set had broken at the upper fitment connection to the syringe adapter.There was no report of consequence or impact to a patient from any event involving the product.No further information was provided.
Event or Problem Description
The customer received the iv tubing sets from staff with no information, and reported that there was an unspecified iv tubing set issue.When the products were received, it was noted that the tubing sets had broken at the upper fitment connection to the syringe adapter.There was no report of consequence or impact to a patient from any event involving the product.No further information was provided.
Additional Manufacturer Narrative
Additional information provided: d.11.The customer¿s report that set broke at the syringe adapter site was confirmed.Visual inspection noted the set broken at the spike adaptor.The break occurs between the vented spike and the upper fitment.No other anomalies was observed.Closer inspection of the two exposed surfaces of the broken vented spike component revealed that the broken surfaces were uneven and jagged.In addition, fine vertical lines were observed at the opening/rim of the upper fitment.These observations are an indication of stress and signify that leverage was likely applied at this area causing the break and resulting leak.Functional testing was deemed unnecessary due to the set¿s break.The root cause of the breakage was identified as an outside force being applied to the component.The root cause of the outside force could not be identified.Device history record for model 10010483 could not be performed due to no lot number being provided by customer.

• Brand Name: ALARIS SYRINGE ADAPTER SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10159212
• Report Number: 9616066-2020-01959
• Device Sequence Number: 3299864
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K934095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

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: Health Professional
• Device Model Number: 10010483
• Device Catalogue Number: 10010483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (3)CUROS CAPS, THERAPY DATE UNK