MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE; PISTON SYRINGE

Catalog Number 47439230

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

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

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Pma / 510(k) #: k011369, k122558.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd ultrasafe passive¿ x-series needle guard syringe plunger was dislodged from the syringe and caused leakage.No serious injury or medical intervention was reported.

Manufacturer Narrative

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 meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on the investigation conclusion the defect occurred due to misuse of the combination product.The identified potential causes for plunger pulled out issues are all related to misuse/mishandling of the combination product by the end user.

Event Description

It was reported that bd ultrasafe passive¿ x-series needle guard syringe plunger was dislodged from the syringe and caused leakage.No serious injury or medical intervention was reported.

• Brand Name: BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 8228491
• MDR Text Key: 132523978
• Report Number: 3009081593-2018-00082
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382904745035
• UDI-Public: 382904745035
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 47439230
• Device Lot Number: 7033272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other