MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE - X100L; PISTON SYRINGE

Catalog Number 47450030

Device Problem Failure to Deliver (2338)

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

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

There were multiple pma/510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma/510(k)#: k011369; pma/510(k)#: k122558.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd ultrasafe passive x-series needle guard syringe - x100l the safety mechanism activated before an injection could be made.This occurred on 2 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: nurse reported that while giving an injection the safety mechanism got activated and she could not inject the medication.

Event Description

It was reported that during use of the bd ultrasafe passive¿ x-series needle guard syringe - x100l the safety mechanism activated before an injection could be made.This occurred on 2 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: nurse reported that while giving an injection the safety mechanism got activated and she could not inject the medication.

Manufacturer Narrative

The customer issued a complaint for pre-activated device detected by end user.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 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.H3 other text : see h.10.

• Brand Name: BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE - X100L
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 8970319
• MDR Text Key: 195294014
• Report Number: 3009081593-2019-00202
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 47450030
• Device Lot Number: 7187089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Date Manufacturer Received: 08/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other