MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS1 360 WHITE BLEND; STOPCOCK

Catalog Number 394910

Device Problem Leak/Splash (1354)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use leakage occurred at the connection during infusion with a bd connecta plus1 360 white blend.This occurred on 5 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported bd connecta plus stopcock leaked at connection to a primary set during a lr infusion.

Manufacturer Narrative

H.6.Investigation summary: a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.This prevented our investigation team from conducting a device history review.A sample was submitted for evaluation and testing.No abnormalities could be identified in the returned sample despite attempts to identify the cause using leakage testing and microscopic evaluation of the device.A possible explanation for this phenomena is the sterilization process of all potentially contaminated devices.The high heat of this process is sufficient to result in the deformation of the septum, potentially sealing any openings that would allow the passage of fluid.Conclusion: bd was not able to confirm the customer¿s indicated failure mode in the samples provided.

Event Description

It was reported that during use leakage occurred at the connection during infusion with a bd connecta plus1 360 white blend.This occurred on 5 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: it was reported bd connecta plus stopcock leaked at connection to a primary set during a lr infusion.

• Brand Name: BD CONNECTA PLUS1 360 WHITE BLEND
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9225859
• MDR Text Key: 191278768
• Report Number: 9610847-2019-00639
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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
• Device Operator: Other
• Device Catalogue Number: 394910
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other