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

Catalog Number 394600

Device Problem Air Leak (1008)

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

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown 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 by the nurse that air was present in the bd connecta¿ stopcock tubing.No reports of harm to the patient, injury, or other clinical consequences reported.Found during use.

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this occurrence.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.Dhr could not be reviewed as the lot number is unknown.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means low occurrence.Product is functional tested and no incidents with air bubbles / air in line have been reported.Reviewing our pfmea's, there are proper controls in place to detect product malfunctions.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Based on investigation results to date, root cause for manufacturing process cannot be determined.Based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

• 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: 7490888
• MDR Text Key: 107619538
• Report Number: 9610847-2018-00130
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K74083
• 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: 06/07/2018

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: Nurse
• Device Catalogue Number: 394600
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/07/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other