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

Catalog Number 394600

Device Problem Leak/Splash (1354)

Patient Problems Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

It was reported that the bd connecta¿ stopcock leaked norepinephrine from the right seam of the connector into the patient's bed during use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "with 1 patient now we have had 3 faucets that were found to be leaking.This is right on the seam of the connector.A lot of lines and syringes have changed recently.Indeed, at first we thought it was caused by the syringes without luor lock.The chance of putting some force or putting the syringe just not quite straight into the opening is there, this could possibly cause this problem.It only now appears to be a tap that nor adrenaline runs over.Here we never put a syringe on it so there must be another reason.The patient had high stands nor with falling blood pressure and not responding to increasing the norepinephrine.It appeared that much of this medication was running in the bed causing low blood pressure for +/- 10-15 minutes as what was agreed upon.".

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H5: imdrf annex e grid: e2401; h5: imdrf annex f grid: f24.

Event Description

It was reported that the bd connecta¿ stopcock leaked norepinephrine from the right seam of the connector into the patient's bed during use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "with 1 patient now we have had 3 faucets that were found to be leaking.This is right on the seam of the connector.A lot of lines and syringes have changed recently.Indeed, at first we thought it was caused by the syringes without luor lock.The chance of putting some force or putting the syringe just not quite straight into the opening is there, this could possibly cause this problem.It only now appears to be a tap that nor adrenaline runs over.Here we never put a syringe on it so there must be another reason.The patient had high stands nor with falling blood pressure and not responding to increasing the norepinephrine.It appeared that much of this medication was running in the bed causing low blood pressure for +/- 10-15 minutes as what was agreed upon.".

Manufacturer Narrative

Correction: b.3.Date of event: 12-may-2023.The following fields were updated due to additional information: d10: device available for eval :yes d10: returned to manufacturer on: 28-jun-2023.H6: investigation summary : it was reported there was leakage on the seam of the connector.To aid in the investigation, one sample and two photos were provided for evaluation by our quality team.A visual inspection was performed and there was a crack observed in port b.The unit was leak tested underwater with a leak observed near the crack of port b.The two photos provided show a drop of water in the connection of port b of the component.This defect does not occur during the assembly process but is attributed to exerting pressure on the connection of the components.It is recommended to refer to the instructions for use, which is located in each box.A device history record review was completed for provided material number 394600, lot 2312150.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), 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.To date, there have been no other similar events reported for this lot.Based on the investigation, bd was able to confirm the customer's indicated failure mode of leakage.

Event Description

It was reported that the bd connecta¿ stopcock leaked norepinephrine from the right seam of the connector into the patient's bed during use.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "with 1 patient now we have had 3 faucets that were found to be leaking.This is right on the seam of the connector.A lot of lines and syringes have changed recently.Indeed, at first we thought it was caused by the syringes without luor lock.The chance of putting some force or putting the syringe just not quite straight into the opening is there, this could possibly cause this problem.It only now appears to be a tap that nor adrenaline runs over.Here we never put a syringe on it so there must be another reason.The patient had high stands nor with falling blood pressure and not responding to increasing the norepinephrine.It appeared that much of this medication was running in the bed causing low blood pressure for +/- 10-15 minutes as what was agreed upon.".

• 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: 17032883
• MDR Text Key: 317444099
• Report Number: 9610847-2023-00131
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 07/31/2023

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: 394600
• Device Lot Number: 2312150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 07/11/2023; 07/31/2023
• Supplement Dates FDA Received: 07/28/2023; 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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