MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE X100L PNG CLEAR NVS STEIN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 47439230

Device Problems Break (1069); Difficult or Delayed Activation (2577)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the customer issued a complaint for pre-activated device detected by end user.Neither sample nor photo was provided to bd medical pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint met all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.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 a ultrasafe x100l png clear nvs stein had a broken safety device during use.The following was reported by the initial reporter: "consumer stated she attempted to use the syringe, spring went over needle cap before having the opportunity to remove and plunger came loose from the guard wings causing medication to leak.Premature activation of the nsd sample investigated in (b)(6) as a premature activation of the nsd.".

• Brand Name: ULTRASAFE X100L PNG CLEAR NVS STEIN
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer (Section G): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11458210
• MDR Text Key: 251093743
• Report Number: 3009081593-2021-00012
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 47439230
• Device Lot Number: 8312560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• 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