MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS3 WHITE PEGS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394601

Device Problem Crack (1135)

Patient Problem Embolism/Embolus (4438)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd connecta plus3 white pegs air formed in the line because of a crack.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the patient suffered from severe infection, severe systemic inflammatory response, and acute renal failure, requiring blood purification treatment.At 16:00 on march 24th, the connecta stopcocks was used to connect the patient's hemofiltration catheter and the extracorporeal circulation line when performing blood purification.After the blood was drawn, a large number of air bubbles appeared at the connecta stopcocks, causing part of the gas to be reinfused through the central venous hemofiltration catheter.In the body, the blood purification cannot be stopped due to a large gas embolism.After the incident, the patient's blood pressure dropped by 86/52mmhg transiently, and the fluid infusion rate was adjusted immediately to assist in taking the left head down and feet up position.After about 5 minutes, the patient's blood pressure gradually returned to the normal level of 110/63mmhg.It will continue to be closely monitored and plan to start crrt treatment again at an optional time.It was found that there was a crack in the connecta stopcocks.

Manufacturer Narrative

Investigation summary: it was reported a large number of air bubbles appeared at the connecta stopcocks, causing part of the gas to be reinfused through the central venous hemofiltration catheter.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 394601, lot 2221431.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 non conformances, capas or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Damages like these on the stopcock housing do not occur in our production.The appearance of these cracks is typical for cracks that can occur when the product has been used together with lubrication solution or infusion with high ph-value.These solutions can release internal stress in the product.If excessive force is used when connecting and using the product for more than 24 hours, this may cause the material to crack.

Event Description

It was reported while using bd connecta plus3 white pegs air formed in the line because of a crack.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the patient suffered from severe infection, severe systemic inflammatory response, and acute renal failure, requiring blood purification treatment.At 16:00 on c, the connecta stopcocks was used to connect the patient's hemofiltration catheter and the extracorporeal circulation line when performing blood purification.After the blood was drawn, a large number of air bubbles appeared at the connecta stopcocks, causing part of the gas to be reinfused through the central venous hemofiltration catheter.In the body, the blood purification cannot be stopped due to a large gas embolism.After the incident, the patient's blood pressure dropped by 86/52mmhg transiently, and the fluid infusion rate was adjusted immediately to assist in taking the left head down and feet up position.After about 5 minutes, the patient's blood pressure gradually returned to the normal level of 110/63mmhg.It will continue to be closely monitored and plan to start crrt treatment again at an optional time.It was found that there was a crack in the connecta stopcocks.

• Brand Name: BD CONNECTA PLUS3 WHITE PEGS
• 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 ; 8448235433
• MDR Report Key: 16748129
• MDR Text Key: 313390890
• Report Number: 9610847-2023-00089
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903946013
• UDI-Public: (01)00382903946013
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: 2221431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2022
• 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
• Patient Outcome(s): Required Intervention