MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS3 WHITE; STOPCOCK, I.V. SET

Catalog Number 394600

Device Problem Leak/Splash (1354)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd connecta plus3 white had connection issues and leakage the following information was provided by the initial reporter: i wanted to report to you that the taps connecting the infusion routes to the patient's venous access that we have, screw in with extreme difficulty and very frequently come loose, causing blood, drugs and liquids to leak out.This morning, although i had screwed them in myself and checked them, they came off twice with two different patients.The taps are bd connecta, i hope a solution can be found soon for patient safety.

Event Description

- could you please provide a date of event? = 10 january, but the ease of disconnection also occurred on the previous days.- has there been any patient impact (serious injury, medical intervention, change of treatment required)? = no.- has there been any healthcare worker¿s exposure to blood or bodily fluids? = yes, spillage of blood, fluids and drugs.- have any other actions been taken? = no.- please confirm if the used samples have been contaminated with blood or cytotoxic medication.If yes please mention the name of it.= yes, blood.No cytotoxic drugs.- whether sample available for investigation? sterile samples from the same batch.- please also provide us with the full pickup address, contact name and number, department name, floor number, and any additional details such as (pick up at reception, goods in yard, etc.) and we will schedule sample pick-up request for you using tnt carrier.= at my address in arcore, via casati 100.- if it is not possible to return the physical sample, can you provide detailed photographs of the affected product? = at the moment we do not know if it is available.

Manufacturer Narrative

Our quality engineer inspected the 1 photo and 12 unused samples submitted for evaluation.The reported issue of connection issue was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that there were no observable abnormalities or defects.All 12 samples underwent functional testing and they all connected to a separate device without failure.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the samples.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

Manufacturer Narrative

Changed the b code to better fit the sample received.

Event Description

No additional information.

• Brand Name: BD CONNECTA PLUS3 WHITE
• Type of Device: STOPCOCK, I.V. 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18625854
• MDR Text Key: 334633452
• Report Number: 9610847-2024-00020
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394600
• Device Lot Number: 3226785
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1