MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NOVARTIS PHARMA - ULTRASAFE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

"unknown manufacturer: (b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: the customer issued a complaint for can¿t activate problem detected by end user.Neither sample nor photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps did not perform a batch history record¿s review (bhr) as batch number of the device is unknown.Based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.".

Event Description

It was reported that an unspecified novartis pharma - ultrasafe had a safety guard that could not be activated during use.The following was reported by the initial reporter: "nsd doesn't activate".

• Brand Name: UNSPECIFIED BD NOVARTIS PHARMA - ULTRASAFE
• 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: 11692720
• MDR Text Key: 246236145
• Report Number: 2243072-2021-01204
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1