MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS3 WHITE BLEND W/O NUT OEM; STOP COCK

Catalog Number 395180

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the direction of the stopcock is incorrect with a bd connecta¿ plus3 white blend w/o nut oem.This occurred on 2 separate occasions prior to use.The following information was provided by the initial reporter, translated from (b)(6) to english: the direction of the stopcock is incorrect.

Manufacturer Narrative

Investigation summary: upon confirmation of the actual product we received, the direction of the stopcock on the three-way stopcock was not normal as suggested.As a reference, we confirmed the samples we stored (products stored for each serial number * n = 3) and found no abnormality.This product had undergone a visual inspection immediately before the individual packaging was put in, but no record of the same defect was found, and the cause could not be identified.This event was the first issue, and we re-instructed manufacturing personnel to pay attention to the assembly process and appearance inspection at the manufacturing site.Customers are advised to replace the product with a new one instead of using it when an abnormality is found.

Event Description

It was reported that the direction of the stopcock is incorrect with a bd connecta¿ plus3 white blend w/o nut oem.This occurred on 2 separate occasions prior to use.The following information was provided by the initial reporter, translated from japanese to english: the direction of the stopcock is incorrect.

• Brand Name: BD CONNECTA¿ PLUS3 WHITE BLEND W/O NUT OEM
• Type of Device: STOP COCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9310709
• MDR Text Key: 191726884
• Report Number: 9610847-2019-00676
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395180
• Device Lot Number: 3339421
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other