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

Catalog Number 47451130

Device Problems Break (1069); Defective Component (2292)

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

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 3 bd ultrasafe plus¿ passive needle guards had issues with the users having difficulty activating the safety guard, as well as the safety devices breaking during compression testing.The following information was provided by the initial reporter: "we are performing following functionality tests on ultrasafe passive plus device.1.Needle safety shield activation force (plunger activation force).2.Needle safety shield override force (compression test).These functional tests are included in our stability program, during stability testing at 24 month timepoint we observed that 3 out of 30 devices are failing in compression test.The recorded forces are 12n, 13n and 27n.We have following observations on tested samples ¿ in two samples all four fingers are in broken condition.And in one sample only two fingers are in broken condition.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28-oct-2022.The customer issued a complaint for compression test failure detected during stability test.33 samples, photos and measurement results were 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 meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer or correlate this symptom with a potential cause linked to bd process.H3 other text : see h10.

Event Description

It was reported that 3 bd ultrasafe plus¿ passive needle guards had issues with the users having difficulty activating the safety guard, as well as the safety devices breaking during compression testing.The following information was provided by the initial reporter: "we are performing following functionality tests on ultrasafe passive plus device.Needle safety shield activation force (plunger activation force).Needle safety shield override force (compression test).These functional tests are included in our stability program, during stability testing at 24 month timepoint we observed that 3 out of 30 devices are failing in compression test.The recorded forces are 12n, 13n and 27n.We have following observations on tested samples ¿ in two samples all four fingers are in broken condition.And in one sample only two fingers are in broken condition.".

• 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: 15482097
• MDR Text Key: 306410511
• Report Number: 3009081593-2022-00005
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382904745110
• UDI-Public: (01)00382904745110
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K123743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47451130
• Device Lot Number: 0013216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2020
• 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