MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 BLUE BLEND; STOPCOCK

Catalog Number 394901

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 2 connecta plus3 blue blend packaging units were found opened before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "of 50 packages in a shelf carton, 2 were opened.".

Manufacturer Narrative

H6: investigation summary: a device history record review was performed for provided lot number 9262741 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation samples were returned to bdj and photos were sent within our manufacturing facility for further evaluation.Through examination of the pictures, the packages were observed open.An exact cause related to the manufacturing process could not be identified at this time for the observed defect.The packaging process is completed by an automated machine and no issues were identified with this machine during the production of this lot.

Event Description

It was reported that 2 connecta plus3 blue blend packaging units were found opened before use.The following information was provided by the initial reporter, translated from japanese to english: "of 50 packages in a shelf carton, 2 were opened.".

• Brand Name: CONNECTA PLUS3 BLUE 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: 10638982
• MDR Text Key: 227049320
• Report Number: 9610847-2020-00312
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 394901
• Device Lot Number: 9262741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other