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

Catalog Number	385163
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 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 acacia extension sets w/ bd q-syte¿ luer access split septum device was having flow issues.This occurred on 2 occasions after use.The following information was provided by the initial reporter: stopper easily detaching, difficulty in flushing & allowing back flow.
Additional Manufacturer Narrative
Investigation summary: received a bd bi-extension set with 2 q-syte units connected to each of its ends.The ext.Set was received within an open package from lot number 8057602 ref 385163.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Visual examination: q-syte 1 ¿ no physical-mechanical damage was observed on the top disk or the column wall.Q-syte 2 - no physical-mechanical damage was observed on the top disk or the column wall.Functional and flush: using a lab provided syringe (both luer slip and luer lock) filled with water/food coloring mixture flushed both q-syte units.Flushing was successful, the liquid went into the q-syte units through the tubing and out the male end of the extension set.No back flow occurred.Connections were performed smoothly and stayed secured.No disconnections occurred.Conclusion(s): indeterminate: the returned units did not display any adverse characteristics that would contribute to the defect the customer experienced, and the failure described in the event description could not be replicated at the laboratory.
Event or Problem Description
It was reported that acacia extension sets w/ bd q-syte¿ luer access split septum device was having flow issues.This occurred on 2 occasions after use.The following information was provided by the initial reporter: stopper easily detaching, difficulty in flushing & allowing back flow.

• 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: 9178496
• Report Number: 9610847-2019-00612
• Device Sequence Number: 2606947
• 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): 11/04/2019

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: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 385163
• Device Lot Number: 8057602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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