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

Catalog Number	385101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
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 bd q-syte¿ luer access split-septum had a valve dysfunction.This was discovered after use.The following information was provided by the initial reporter: valve dysfunction.
Event or Problem Description
It was reported that bd q-syte¿ luer access split-septum had a valve dysfunction.This was discovered after use.The following information was provided by the initial reporter: valve dysfunction.
Additional Manufacturer Narrative
Investigation summary: received a q-syte assembly connected to an extension set with no packaging information.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Visual examination: the q-syte assembly was severely occluded with patient residue (blood) (the unit was flushed with bleach/water solution).A small tear was observed on the slit of the septum top disk.Tears were observed on the slit of the bottom septum disk (dissected after leak test).No damage was found on the column wall (dissected after observation and leak test).Water-leak test: the unit was tested by connecting the male luer end of the q-syte to the water-leak fixture.The unit was tested on both the actuated and the unactuated positions.No leakage was observed on any of the components of the unit on either of the positions.Conclusion(s): root cause not determined ¿ a definite source that caused the damage (tears) on the top and bottom slits could not be determined, this damage is normally attributed to incorrect usage or excessive actuation.Since the customer failed to explain what the detailed failure was a root cause was not determined.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM
• 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: 9218094
• Report Number: 9610847-2019-00636
• Device Sequence Number: 19607029
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 11/25/2019

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: 09/30/2023
• Device Catalogue Number: 385101
• Device Lot Number: 8332626
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/25/2019
• 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