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

Catalog Number 394602

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2020

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.(b)(4).

Event Description

It was reported that the bd connecta¿ stopcock experienced device damage/deformation while still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: the patient was admitted to the comprehensive internal medicine department on (b)(6) 2020, and was diagnosed with lung infection.At 09:36 on (b)(6) 2020, when the nurse performed two bottles of liquid for him at the same time, use the connecta for infusion, the outer packaging of the connecta is intact, after opening, check the appearance for cracks, immediately replaced the patient with a new one for infusion, it can easily cause retrograde infection.

Manufacturer Narrative

H6: investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9274133.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect signs of damage during the production process.It is possible that the damage resulted from a forceful connection prior to infusion.Cracking can also result from the type of medication used.Further action has not been determined necessary at this time.H3 other text : see h.10.

Event Description

It was reported that the bd connecta¿ stopcock experienced device damage/deformation while still considered operable.Product defect was noted prior to use.The following information was provided by the initial reporter: the patient was admitted to the comprehensive internal medicine department on (b)(6) 2020, and was diagnosed with lung infection.At 09:36 on (b)(6) 2020, when the nurse performed two bottles of liquid for him at the same time, use the connecta for infusion, the outer packaging of the connecta is intact, after opening, check the appearance for cracks, immediately replaced the patient with a new one for infusion, it can easily cause retrograde infection.

• 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: 10687586
• MDR Text Key: 225535108
• Report Number: 9610847-2020-00323
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 394602
• Device Lot Number: 9274133
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other