MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE X100L PNG CLEAR NVS STEIN; PISTON SYRINGE

Catalog Number 47439230

Device Problem Unintended Ejection (1234)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Pma / 510(k)#: k011369, k122558.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

The following was reported when using a ultrasafe x100l png clear nvs stein, "study nurse report the affected syringe ejected to the grip at the opening of the box.The injection is possible but without the element of the protective spring.".

Manufacturer Narrative

Investigation: neither photo nor sample 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 meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on investigation conclusion a syringe can only become detached if syringe capture features or the flange of the syringe get damaged/broken or if the syringe receives an impact after syringe insertion which causes it to unclip from the device.Therefore, the syringe most likely became detached as it was not clipped into the device properly or it received an external impact after syringe insertion which caused it to unclip from the device.None of these causes are related to bd process.

Event Description

The following was reported when using a ultrasafe x100l png clear nvs stein, "study nurse report the affected syringe ejected to the grip at the opening of the box.The injection is possible but without the element of the protective spring.".

• Brand Name: ULTRASAFE X100L PNG CLEAR NVS STEIN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 8391747
• MDR Text Key: 138354319
• Report Number: 3009081593-2019-00115
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 47439230
• Device Lot Number: 7114347
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other