MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD; ANTISTICK SYRINGE

Catalog Number 47451130

Device Problem Activation Problem (4042)

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

Event Date 09/21/2022

Event Type  malfunction  

Event Description

It was reported that the user could not activate the safety guard for the bd ultrasafe plus¿ passive needle guard.The following information was provided by the initial reporter: we had a needle that did not retract after release.Was someone (patient, health care worker, etc.) affected/harmed? if yes, please provide more information: death, no drug administration, serious public health threat, serious deterioration of health, delayed treatment ¿ no adrs reported with complaint.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: the customer issued a complaint for can¿t inject/activate problem detected by end user.No sample or photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Based on the description bd assigned a quality criteria that is related to the reported condition and identified in the agreed specification.After reviewing the occurrence, irrespective of root cause, it is within the specification and no further action will be assigned.The report will not be updated if the sample is received after the approval of this report.The batch was manufactured and released according to applicable procedures and specifications.Consequently, bdm-ps will not define corrective or preventive actions following the investigation of this complaint.This complaint is registered in bd complaint system and trend analysis will be performed.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.During the years of investigation of complaints about pre-activated devices several root causes were discovered which were within the customer¿s sphere of influence.H3 other text : see h10.

Manufacturer Narrative

H6: investigation summary: no sample or photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Based on the description bd assigned a quality criteria that is related to the reported condition and identified in the agreed specification.After reviewing the occurrence, irrespective of root cause, it is within the specification and no further action will be assigned.The report will not be updated if the sample is received after the approval of this report.As this is a market event, the reported condition detected is not part of a sampling plan that allows to conclude about the whole batch, therefore the aql is not applicable.The batch was manufactured and released according to applicable procedures and specifications.Consequently, bdm-ps will not define corrective or preventive actions following the investigation of this complaint.This complaint is registered in bd complaint system and trend analysis will be performed.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 the user could not activate the safety guard for the bd ultrasafe plus¿ passive needle guard.The following information was provided by the initial reporter: we had a needle that did not retract after release.Was someone (patient, health care worker, etc.) affected/harmed? if yes, please provide more information: death, no drug administration, serious public health threat, serious deterioration of health, delayed treatment.No adrs reported with complaint.

• Brand Name: BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD
• Type of Device: ANTISTICK SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15620569
• MDR Text Key: 307199439
• Report Number: 3009081593-2022-00007
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47451130
• Device Lot Number: 0247567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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