MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHETER

Catalog Number UNKNOWN

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

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 in 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: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: 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.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.

Event Description

It was reported that unspecified bd¿ catheter had air in line.The following information was provided by the initial reporter: material no.: unknown, batch no.: unknown.It was reported that air was present in the second lumen of the dual port catheter.Per pir: air in the second lumen of nexiva dual port.A new radiologist detected air.They have been using this device for several years with no concerns.The customer does not have the lot or product reference code because the sample was thrown out.I've asked her to keep the same and collect this info if it happens again.We have sent trouble shooting tips and put them in touch with a reference account.

• Brand Name: UNSPECIFIED BD CATHETER
• Type of Device: CATHETER
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10987694
• MDR Text Key: 221287327
• Report Number: 2243072-2020-02036
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• 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: 11/13/2020
• 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