MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE BI-EXTENSION SET 15 CM (6 IN) 0.45 ML; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 385157

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

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 has been reported that the bd q-syte bi-extension set 15 cm (6 in) 0.45 ml has been found experiencing 15 occurrences of blood backflow during use.The following has been provided by the initial reporter: back flow issue.

Event Description

It has been reported that the bd q-syte bi-extension set 15 cm (6 in) 0.45 ml has been found experiencing 15 occurrences of blood backflow during use.The following has been provided by the initial reporter: back flow issue.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaint could not be confirmed and root cause is undetermined.H3 other text : see h.10.

• Brand Name: BD Q-SYTE BI-EXTENSION SET 15 CM (6 IN) 0.45 ML
• 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: 9521769
• MDR Text Key: 195408282
• Report Number: 9610847-2019-00768
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K142527
• 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: 02/04/2020

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
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 385157
• Device Lot Number: 9122779
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other