MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CONNECTA; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Leak/Splash (1354); Free or Unrestricted Flow (2945); Infusion or Flow Problem (2964); Packaging Problem (3007)

Patient Problems Air Embolism (1697); Unspecified Infection (1930)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.

Event Description

It was reported that unspecified bd¿ connecta had air in the line, flow issues, leakage, disconnected stopcock, kinked tubing, and open package.The following information was provided by the initial reporter: material no: unknown batch no: unknown.It was reported via post market survey that the clinician encountered occurrences of infection (blood stream bacteraemia, sepsis etc.) (10), air embolism (1), no flow or reduced flow of fluids (45), free or unrestricted flow (1), leakage (3), stopcock inadvertently disconnects from mating component (49), tubing disconnects from stopcock (11), tubing kinked (33), and package seal open before use (1).

• Brand Name: UNSPECIFIED BD CONNECTA
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11358318
• MDR Text Key: 241451486
• Report Number: 2243072-2021-00495
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other