MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD IV EXTENSION SETS WITH THREE-WAY STOPCOCKS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 395000

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported that 3 bd iv extension sets with three-way stopcocks were labeled with 4-way stopcock without extension.The following information was provided by the initial reporter.Connecta plain cartons mentioned as four-way stop cock instead of three way stop cock.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2028053.Medical device expiration date: 31-dec-2024.Device manufacture date: 15-feb-2022.Medical device lot #: 2006871.Medical device expiration date: 31-dec-2024.Device manufacture date: 31-jan-2022.Medical device lot #: 1306052.Medical device expiration date: 31-oct-2024.Device manufacture date: 30-nov-2021.

Event Description

It was reported that 3 bd iv extension sets with three-way stopcocks were labeled with 4-way stopcock without extension.The following information was provided by the initial reporter: connecta plain cartons mentioned as four-way stop cock instead of three way stop cock.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of label content incorrect was confirmed upon inspection photo.Bd determined that the cause of the failure was related to the labeling process during manufacturing.This issue has been investigated and actions have been made to address this labeling issue.The device history records (dhr) review was performed for the lot number material identified in this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.H3 other text : see h10.

• Brand Name: BD IV EXTENSION SETS WITH THREE-WAY STOPCOCKS
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15422087
• MDR Text Key: 305711676
• Report Number: 9610847-2022-00348
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395000
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1