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

Catalog Number 394945

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/07/2018

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 fluid leaked from the bd connecta¿ stopcock during use.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that fluid leaked from the bd connecta¿ stopcock during use.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: 11 samples of batch 8037509 were evaluated and 1 sample of batch 8066815.For batch 8037509 only 3 samples reported showed the defect reported (leakage), two of them shows the leakage by injection valve and one sample shows a cracked in port b.Six samples evaluated didn¿t show issue reported (leakage).For batch 8066815 the leakage was detected in the section of injection valve.For batch 8037509 were received 2 additional samples on (b)(6) 2018, that don¿t shown the defect reported by the customer.The device history records (dhr) review was performed for the lots numbers 8037509, 8066815, material 394945 identified in the complaint (b)(4).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), capa¿s 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.This product 8066815 was manufactured on march-27-2018 by equipment ka56.The product 8037509 was manufactured on february-28-2018 by equipment ka56.For leakage issue based on sample evaluation leakage/air in injection valve have been detected, the team previously confirmed issues with this product lot 8037509 where leakage occurred at the valve port 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.For cracked port b bd was not able to duplicate the customer¿s indicated failure mode during our manufacturing process.Based on sample evaluation, we found cracks on port b housing component leading to leakage (air bubbles); however, we were not able to associate these cracks to the mfg.Process.Quality records have been consulted for tracking and trending purposes but issues like this are not detected which means low occurrence.Bd will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Process fmea rm5943 and process eura eurap2053001 were reviewed and there are proper controls in place to detect product malfunctions.Nogales will open a capa (#629955) not because of the cid as it is ¿no capa required¿ as per cpr-028 based on the severity and occurrence calculation, the reason to open the capa is to better support the exposure to external stakeholders, the focus of the capa will be batch 8037509 and sub-assembly lots related to that batch.

• 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: 7899735
• MDR Text Key: 121585378
• Report Number: 9610847-2018-00324
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8037509
• Date Manufacturer Received: 09/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other