MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK

Catalog Number 395061

Device Problem Inaccurate Information (4051)

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

Event Date 08/19/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

T was reported that the bd connecta¿ stopcock box label read "mrp rs.339" while the individual product was labeled as "mrp.Rs.308.50".The following information was provided by the initial reporter: "connecta 100 cm- mrp rs.339 is printed in the outer box.Where as mrp.Rs.308.50 is printed in individual product.".

Manufacturer Narrative

H.6.Investigation summary: it was reported the mrp is different on the shelf box and individual product.To aid in the investigation, two photos were received for evaluation by our quality team.A visual inspection was performed and the different mrp was observed and confirmed.A device history record (dhr) review was completed for provided material number 395061, lot 2257120.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s), corrective actions or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the processes and/or equipment that would have affected the manufacturing of the device.Maintenance records were evaluated, and no problems were found.As a corrective action, the format was modified for verification of the mrp number when printing the shipper labels to coincide with the correct number assigned by the work order.The unit package number will also be verified at the beginning of the order to ensure no discrepancy in the mrp number.Based on the investigation, bd was able to confirm the customer¿s indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported that the bd connecta¿ stopcock box label read "mrp rs.339" while the individual product was labeled as "mrp.Rs.308.50".The following information was provided by the initial reporter: "connecta 100 cm- mrp rs.339 is printed in the outer box.Where as mrp.Rs.308.50 is printed in individual product.".

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17711318
• MDR Text Key: 322963771
• Report Number: 9610847-2023-00254
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K974083
• 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: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395061
• Device Lot Number: 2257120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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