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

Catalog Number 47439230

Device Problem Failure to Deliver (2338)

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

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(b)(6).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 during use of a bd ultrasafe passive¿ x-series needle guard syringe, the prefilled syringe pens plunger would not release the medication.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that during use of a bd ultrasafe passive x-series needle guard syringe, the prefilled syringe pens plunger would not release the medication.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

The customer issued a complaint for a difficult to inject of 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 meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.It should be noted that tests performed by bd tatabanya during production controls are related to the assembled device, without using syringe and plunger rod.Testing of combination product is out of scope for safety device manufacturing.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.

• 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: 7889695
• MDR Text Key: 120973404
• Report Number: 3009081593-2018-00062
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382904745035
• UDI-Public: 382904745035
• Combination Product (y/n): N
• PMA/PMN Number: K011369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 47439230
• Device Lot Number: 7114347
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other