MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ 3-WAY STOPCOCK

Catalog Number 394602

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the bd connecta¿ 3-way stopcock leaked medication while the patient was sedated.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from german to english: "the 3-way-stopcock was used with a patient in prone position who was sedated.There was a leakage of the medication and the patient woke up from sedation, the patient had to be sedated again.Given the patient was under artificial respiration, the artificial respiration had to be adjusted again as well.".

Manufacturer Narrative

H.6.Investigation: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

Event Description

It was reported that the bd connecta¿ 3-way stopcock leaked medication while the patient was sedated.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from german to english: "the 3-way-stopcock was used with a patient in prone position who was sedated.There was a leakage of the medication and the patient woke up from sedation, the patient had to be sedated again.Given the patient was under artificial respiration, the artificial respiration had to be adjusted again as well.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 2202-02-01.H6: investigation summary: our quality engineer inspected the 4 samples submitted for evaluation.The reported issue was confirmed upon testing of the samples.The 4 samples underwent our internal leakage testing and 3 of the 4 samples showed leakage.It was determined that the leakage was occurring due to a crack found at the c port of the device.Bd did not determine a manufacturing root cause since the crack found tends to occur when the product is used with either a lubrication solution or with infusions with a high ph-value.Those solutions can release internal stresses in the device resulting in cracking if excessive force is applied to the device for an extended period of time greater than 24 hours.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A device history record review of the reported lot showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that the bd connecta¿ 3-way stopcock leaked medication while the patient was sedated.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from german to english: "the 3-way-stopcock was used with a patient in prone position who was sedated.There was a leakage of the medication and the patient woke up from sedation, the patient had to be sedated again.Given the patient was under artificial respiration, the artificial respiration had to be adjusted again as well.".

• Brand Name: BD CONNECTA¿ 3-WAY 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12636984
• MDR Text Key: 277180614
• Report Number: 9610847-2021-00499
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/06/2021

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 Expiration Date: 08/31/2022
• Device Catalogue Number: 394602
• Device Lot Number: 9270599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/27/2021; 02/10/2022
• Supplement Dates FDA Received: 11/17/2021; 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• 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