MAUDE Adverse Event Report: CAREFUSION SE W/CV & 2 VLV PORTS 20 DRP; INTRAVASCULAR ADMINISTRATION SET

Model Number	72023E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that se w/cv & 2 vlv ports 20 drp was cracked.The following information was provided by the initial reporter: the reported feedback suggests that there is a cracked alaris se iv line.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 09/07/2020.Investigation conclusion one 72023e sample was received for investigation with residual fluid in the line; no packaging was received with the sample and the lot number could not be determined in this instance.A visual inspection identified a small crack located at the frontal lower section of the accuslide component.Leakage was confirmed from the damaged component during flushing.The details of this feedback were forwarded to the manufacturing site for investigation.Previous investigations performed by the manufacturing site have identified that this type of fracture is most likely caused by material fatigue, which can occur if the accuslide is subjected to repeated loading and unloading; however in this instance without the pump in clinical use at the time of the incident it was not possible to confirm the exact root cause for the cracking.Please note, all accuslide components are 100% leak tested prior to being assembled in the infusion set.A lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.In this instance, it was not possible to confirm the root cause of the reported issue; however it is unlikely that a manufacturing defect resulted in the observed damage.A review of the customer feedback database indicates that this is a rare occurrence with one similar report against the accuslide component in the past 12 months.
Event or Problem Description
It was reported that se w/cv & 2 vlv ports 20 drp was cracked.The following information was provided by the initial reporter: the reported feedback suggests that there is a cracked alaris se iv line.

• Brand Name: SE W/CV & 2 VLV PORTS 20 DRP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10471263
• Report Number: 9616066-2020-02593
• Device Sequence Number: 2750857
• Product Code: FPA
• UDI-Device Identifier: 07613203010276
• UDI-Public: 07613203010276
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K931550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: Other
• Device Model Number: 72023E
• Device Catalogue Number: 72023E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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: 20200809.; 20200809.
• Outcome Attributed to Adverse Event: Other