MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ACACIA EXTENSION SETS W/ BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number	385163
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the acacia extension sets w/ bd q-syte¿ luer access split septum device there was an issue with leakage with the q syte device detached from the extension while connected to the administration set.The following information was provided by the initial reporter: the q syte device detached from the extension while connected to the administration set.This happened during a surgical procedure in theater and was only realized long after all the fluids and iv drugs had drained into the linen.
Additional Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed for provided lot number 8057602 and the review did not reveal any detected abnormalities during the production process that could have contributed to the reported incident.To further investigate this issue, one representative sample was provided for evaluation by our quality team.Through examination of the provided sample, no damages were observed.The sample was then functionally tested and no signs of leakage were observed nor were any signs of damage from torque removal of the q-syte observed.Based on the investigation results, a cause for this incident could not be determined.At this time, further action has not been determined necessary; however, our quality team will continue to monitor the production process for signs of this defect and other emerging trends.
Event or Problem Description
It was reported that during use of the acacia extension sets w/ bd q-syte¿ luer access split septum device there was an issue with leakage with the q syte device detached from the extension while connected to the administration set.The following information was provided by the initial reporter: the q syte device detached from the extension while connected to the administration set.This happened during a surgical procedure in theater and was only realized long after all the fluids and iv drugs had drained into the linen.

• Brand Name: ACACIA EXTENSION SETS W/ BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM DEVICE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9546061
• Report Number: 9610847-2019-00799
• Device Sequence Number: 3445920
• Product Code: FPA
• UDI-Device Identifier: 50382903851633
• UDI-Public: 50382903851633
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 385163
• Device Catalogue Number: 385163
• Device Lot Number: 8057602
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other