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	Inadequate Pain Relief (2388)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device 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
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 on three separate occasions on two separate patients causing the patients to lose their pain relief.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 epidural tubing cracked and leaked was not confirmed.The set samples were not received for evaluation.No root cause was able to be identified.The device history record for model 30893-07 lot 19025228 shows the set was manufactured on 06feb2019 with a total of 6,003 units.There was a quality notification issued for leak (200303047) during the production build of this set in which affected product was identified, segregated, and a global hold ship notification done.Although the issue could not be confirmed because no product was returned, this model and lot are included in the medical device recall notification (z-1967-2020).
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 on three separate occasions on two separate patients causing the patients to lose their pain relief.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.

• 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: 9960898
• Report Number: 9616066-2020-01311
• Device Sequence Number: 16780928
• 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
• Remedial Action: Recall
• Type of Report: Initial,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?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1967-2020
• Patient Sequence Number: 1