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

Catalog Number 394602

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/05/2023

Event Type  malfunction  

Manufacturer Narrative

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¿ stopcock the cap was loose and could not be tightened.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital due to coronary heart disease, and returned to the ward after coronary artery bypass grafting.Esmolol was pumped at 16:40 on (b)(6) 2023, and the jugular vein channel was increased.If it cannot be tightened, replace it with a new one immediately, without causing loss or injury to the patient.

Manufacturer Narrative

H6: investigation summary it was reported there was a connection issue.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 394602, lot 2122315.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.

Event Description

It was reported while using bd connecta¿ stopcock the cap was loose and could not be tightened.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital due to coronary heart disease, and returned to the ward after coronary artery bypass grafting.Esmolol was pumped at 16:40 on march 5, 2023, and the jugular vein channel was increased.If it cannot be tightened, replace it with a new one immediately, without causing loss or injury to the patient.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: 16740806
• MDR Text Key: 313727305
• Report Number: 9610847-2023-00087
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903946020
• UDI-Public: (01)00382903946020
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394602
• Device Lot Number: 2122315
• 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: 05/27/2022
• 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