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

Catalog Number 394945

Device Problems Complete Blockage (1094); Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9281003.Medical device expiration date: 2022-09-30.Device manufacture date: 2019-10-31.Medical device lot #: 9127846.Medical device expiration date: 2022-04-30.Device manufacture date: 2019-06-14.Medical device lot #: 8309833.Medical device expiration date: 2021-10-31.Device manufacture date: 2018-12-21.Medical device lot #: 9309927.Medical device expiration date: 2022-10-31.Device manufacture date: 2019-12-10.Medical device lot #: 9176629.Medical device expiration date: 2022-05-31.Device manufacture date: 2019-07-11.Medical device lot #: 9220680.Medical device expiration date: 2022-07-31.Device manufacture date: 2019-09-24.Medical device lot #: 9281010.Medical device expiration date: 2022-09-30.Device manufacture date: 2019-11-14.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 several bd connecta¿ stopcocks were found with kinks/bends in the tubing, which caused a "worse" flow through them during use.Some tubes were bent back into place, only to be observed to "bend back" during the ongoing flow.Lot#'s 9281003, 9127846, 8309833, 9309927, 9176629, 9220680, and 9281010 were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter: several of the tubing on the stopcocks got a knix/bent tube.The end user have seen this problem for a long time.They have made a complaint about this before, in 2017, and bd then said it works fine anyway.Now they have made some tests and the flow is different, depending on where the knix/bent is, on the stopcock-tube.A large amount of the bended stopcocks-tubes are found in both boxes.This has been reported to bd 2017 with the answer that it does not affect the function.This does the users not agree on, they feel that the flow through the crooked stopcock-tube is worse (especially when they use this connecta 3-way stopcock with a gravity set).This has created a concern among the users and they choose to discard the stopcocks that have crooked tubes.It´s also extra-time-consuming to fix these taps on the patient to keep the flow stable.It also concerns the users, that they don´t know if the tube is open, when it got this bent, when it attaches to the patient.When they fixate it they are afraid the bent tube will go back to be bent again, without the nurse seeing it.They have tested the stopcocks (one with and one without the bent tube) and see that the flow of gravitational drop through the crooked stopcock is unstable and dependent on the where the bent /crook is.They also see that the bended tube bends back during ongoing flow.Two boxes of bd connecta 3-way stopcocks where several of the stopcocks got a knix/bent/crooked on them.They have made a complaint about this before and bd says it works fine anyway.Now they have made some tests and the flow is different, depending on where the kink/knix are, on the stopcock.A large amount of the knitted stopcocks are found in both boxes.This has been reported to bd 2017 with the answer that it does not affect the function.This does the users not agree on, they feel that the flow through the crooked stopcock is worse.This has created a concern among the users and they choose to discard the stopcocks that are crooked.It´s also extra-time-consuming to fix these taps on the patient to keep the flow stable.We have tested the stopcocks and see that the flow of gravitational drop through the crooked stopcock is unstable and dependent on the state of the bent /crook.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-04-09.H.6.Investigation summary a device history record review was performed for provided lot numbers 9281003, 9127846, 8309833, 9309927, 9220680, 9281010 and 9176629.The review did not reveal any detected quality issues during the production process that could have contributed to the reported incident.To aid in the investigation of this issue, two picture samples and one-hundred and sixty-two physical samples were returned for evaluation by our quality engineer team.Through examination of the provided samples, kinked tubing was confirmed for every lot number.It has been determined that the tubing damage is a result of the current tube length; a short tube.In response to this incident, a quality alert was raised to inform the manufacturing facility and any related personnel of this issue.Our quality team will continue to monitor the production process for signs of this defect and any emerging trends.

Event Description

It was reported that several bd connecta¿ stopcocks were found with kinks/bends in the tubing, which caused a "worse" flow through them during use.Some tubes were bent back into place, only to be observed to "bend back" during the ongoing flow.Lot#s 9281003, 9127846, 8309833, 9309927, 9176629, 9220680, and 9281010 were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter: several of the tubing on the stopcocks got a knix/bent tube.The end user have seen this problem for a long time.They have made a complaint about this before, in 2017, and bd then said it works fine anyway.Now they have made some tests and the flow is different, depending on where the knix/bent is, on the stopcock-tube.A large amount of the bended stopcocks-tubes are found in both boxes.This has been reported to bd 2017 with the answer that it does not affect the function.This does the users not agree on, they feel that the flow through the crooked stopcock-tube is worse (especially when they use this connecta 3-way stopcock with a gravity set).This has created a concern among the users and they choose to discard the stopcocks that have crooked tubes.It´s also extra-time-consuming to fix these taps on the patient to keep the flow stable.It also concerns the users, that they don´t know if the tube is open, when it got this bent, when it attaches to the patient.When they fixate it they are afraid the bent tube will go back to be bent again, without the nurse seeing it.They have tested the stopcocks (one with and one without the bent tube) and see that the flow of gravitational drop through the crooked stopcock is unstable and dependent on the where the bent /crook is.They also see that the bended tube bends back during ongoing flow.Two boxes of bd connecta 3-way stopcocks where several of the stopcocks got a knix/bent/crooked on them.They have made a complaint about this before and bd says it works fine anyway.Now they have made some tests and the flow is different, depending on where the kink/knix are, on the stopcock.A large amount of the knitted stopcocks are found in both boxes.This has been reported to bd 2017 with the answer that it does not affect the function.This does the users not agree on, they feel that the flow through the crooked stopcock is worse.This has created a concern among the users and they choose to discard the stopcocks that are crooked.It´s also extra-time-consuming to fix these taps on the patient to keep the flow stable.We have tested the stopcocks and see that the flow of gravitational drop through the crooked stopcock is unstable and dependent on the state of the bent /crook.

• 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
• MDR Report Key: 9881141
• MDR Text Key: 204998868
• Report Number: 9610847-2020-00110
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

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: 394945
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Manufacturer Received: 03/05/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other