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

Catalog Number	385108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd q-syte¿ vial access adapter had a glue like residue where the needle connects.
Event or Problem Description
It was reported that a bd q-syte¿ vial access adapter had a glue like residue where the needle connects.
Additional Manufacturer Narrative
Investigation: review of the dhr disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated.Observations and testing could not be performed because units were not received for investigation of this incident.The defect foreign matter; could not be identified or confirmed, and cause could not be determined, as the units described in the product incident report were not returned for evaluation and testing.

• Brand Name: BD Q-SYTE¿ VIAL ACCESS ADAPTER
• 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
• MDR Report Key: 8279738
• Report Number: 9610847-2019-00106
• Device Sequence Number: 16458519
• Product Code: FPA
• UDI-Device Identifier: 30382903851080
• UDI-Public: 30382903851080
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 05/31/2022
• Device Catalogue Number: 385108
• Device Lot Number: 7178890
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/20/2019
• 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