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

Catalog Number 394945

Device Problems Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8180508, medical device expiration date: 2021-05-31, device manufacture date: 2018-08-30.Medical device lot #: 8066812, medical device expiration date: 2021-02-28, device manufacture date: 2018-05-02.(b)(6).Device evaluated by mfr: 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¿ stopcock leaked medication from the valve during use.The joint at the tubing and valve was reportedly "delicate" and prone to breakage, as well as the caps being "weakly" fixed onto the device before use and causing the potential for them to be easily lost upon removal from the packaging.Additionally, it was reported by the customer that a "contrast" leaked at the scanner and caused a temporary failure.Lot #'s 8180508 and 8066812 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.As reported by the customer, translated from french to english, "several times drug leakage at the valve.Additional information from the customer: a contrast leaked at the scanner and generated a temporary failure.At the injection site, there is no valve, which causes leaks.At the joint tubing / valve, they are delicate and sometimes break.The caps are weakly set so that when they are removed from the package, easy to be lost.".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot numbers 8180508 & 8066812.Our records show that a trend for leakage has been detected in the bd connecta product family.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, our engineers were able to duplicate this event through the leakage testing of the submitted device.A subsequent review of our manufacturing line determined that the most likely root cause for this event is an abnormality in the equipment responsible for tubing assembly.To prevent a reoccurrence of this event we have retrained our personnel and optimized our manufacturing process to monitor this issue more thoroughly.Bd was able to confirm the customer¿s indicated failure mode because the samples received shown leakage, this failure mode was detected in others customer complaints where leakage occurred at the valve port assy.Due to a bad tubing assembly.Engineering team assessed the assembly process finding a worn pin in station 5 that could cause the reported failure mode.This pin is in charge of assembling the gray tubing into the valve housing.Based on investigation results to date, for leakage issue (in injection valve) root cause was associated to a bad tubing assembly by station 5 of equipment vh59.Nogales will open a capa (#(b)(4)) not because of the cid as it is ¿no capa required¿ based on the severity and occurrence calculation, the reason to open the capa is to perform a better investigation.

Event Description

It was reported that the bd connecta¿ stopcock leaked medication from the valve during use.The joint at the tubing and valve was reportedly "delicate" and prone to breakage, as well as the caps being "weakly" fixed onto the device before use and causing the potential for them to be easily lost upon removal from the packaging.Additionally, it was reported by the customer that a "contrast" leaked at the scanner and caused a temporary failure.Lot #'s 8180508 and 8066812 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.As reported by the customer, translated from french to english, "several times drug leakage at the valve.Additional information from the customer: a contrast leaked at the scanner and generated a temporary failure.At the injection site, there is no valve, which causes leaks.At the joint tubing / valve, they are delicate and sometimes break.The caps are weakly set so that when they are removed from the package, easy to be lost.".

• 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
• MDR Report Key: 8391250
• MDR Text Key: 138269599
• Report Number: 9610847-2019-00196
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• 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.
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other