MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO BORE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 385102

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 03/01/2020

Event Type  malfunction  

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 Description

It was reported that bd q-syte extension set 15 cm (6 in) 0.34 ml micro bore leaked from the top of the septum the following information was provided by the initial reporter: "the patient was admitted due to prostatic hyperplasia, and was given intravenous infusion.At 9:00 on the morning of (b)(6) 2020, the responsible nurse found a little bleeding in the diaphragm during the routine rounds of the ward, and immediately gave the replacement without adverse consequences to the patient.".

Manufacturer Narrative

H.6.Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported that bd q-syte extension set 15 cm (6 in) 0.34 ml micro bore leaked from the top of the septum.The following information was provided by the initial reporter: "the patient was admitted due to prostatic hyperplasia, and was given intravenous infusion.At 9:00 on the morning of (b)(6) 2020, the responsible nurse found a little bleeding in the diaphragm during the routine rounds of the ward, and immediately gave the replacement without adverse consequences to the patient.".

• Brand Name: BD Q-SYTE EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO BORE
• Type of Device: 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: 9900498
• MDR Text Key: 202998390
• Report Number: 9610847-2020-00113
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851027
• UDI-Public: 00382903851027
• Combination Product (y/n): N
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 385102
• Device Lot Number: 8274900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other