MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	30893-07
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that in the birthing center, tubing cracked at the hub which resulted in a pain medication leaking below the connection site during patient use.This event did not result in a serious injury, and it was reported it¿s unknown if this event caused a delay or change in the course of treatment.
Additional Manufacturer Narrative
The customer¿s report that the tubing cracked at the hub was confirmed.The customer's report of a leak was not confirmed.Visual inspection under magnification observed a small crack in the anti-siphon wall located at the top edge of the female port.Functional testing did not to replicate any leaks with the returned set as reported by the customer.Pressure testing also found no anomalies.It was determined that the crack did not affect the functionality of the set.The root cause of the customer's report could not be identified.A device history record for model 30893-07 with lot number 19025228 was performed.The search showed that a total of (b)(4) were built in 1 lot on 06feb2019.The search showed that there was one quality notification post production of the set.A global hold on the lot was initiated.
Event or Problem Description
It was reported that in the birthing center, tubing cracked at the hub which resulted in a pain medication leaking below the connection site during patient use.This event did not result in a serious injury, and it was reported it¿s unknown if this event caused a delay or change in the course of treatment.
Event or Problem Description
It was reported that in the birthing center, tubing cracked at the hub which resulted in a pain medication leaking below the connection site during patient use.This event did not result in a serious injury, and it was reported it¿s unknown if this event caused a delay or change in the course of treatment.
Additional Manufacturer Narrative
Additional info: a.1;a.2 disregard comment in b7.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9960896
• Report Number: 9616066-2020-01310
• Device Sequence Number: 11399693
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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,Followup
• Report Date (Section B): 03/24/2020

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 Expiration Date: 02/06/2022
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 19025228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/25/2020; 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1