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

Catalog Number 394605

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd connecta¿ stopcock was observed to have a crack causing leakage.The following information was provided by the initial reporter, translated from chinese to english: one hour after changing the infusion connecta for the patient, the patient developed chest tightness and suffocation, and found that the infusion connecta was leaking, so he replaced it immediately.Observe the replaced connecta and found that there are cracks at the interface and consider the possibility of air embolism in the patient.

Event Description

It was reported that the bd connecta¿ stopcock was observed to have a crack causing leakage.The following information was provided by the initial reporter, translated from chinese to english: one hour after changing the infusion connecta for the patient, the patient developed chest tightness and suffocation, and found that the infusion connect a was leaking, so he replaced it immediately.Observe the replaced connecta and found that there are cracks at the interface and consider the possibility of air embolism in the patient.

Manufacturer Narrative

H6: investigation summary: it was reported the infusion connecta was cracked at the interface and leaking.As a sample was not returned, a thorough sample investigation could not be completed.Damage like this on the stopcock housing do not occur in during production.The appearance of these cracks can occur when the product has been used together with a lubrication solution or infusion with a 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 also cause the material to crack.Please refer to the instructions for use, which is enclosed in each box.As the lot provided is 'unknown,' a device history record review could not be completed.Bd was not able to confirm the customer's indicated failure mode of component damage - leak.Based on the limited investigation results, a cause for the reported incident could not be determined.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16592829
• MDR Text Key: 311788803
• Report Number: 9610847-2023-00067
• Device Sequence Number: 1
• Product Code: FMG
• 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: 03/22/2023

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: 394605
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/22/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 03/30/2023
• 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
• Patient Outcome(s): Required Intervention