MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) X225L BD ULTRASAFE PASSIVE¿ NEEDLE GUARD SYRINGE; PISTON SYRINGE

Catalog Number 47530630

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7086428, medical device expiration date: 2021-02-28, device manufacture date: 2017-03-27.Medical device lot #: 7122132, medical device expiration date: 2021-04-30, device manufacture date: 2017-05-02.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the safety mechanism partially activated on a x225l bd ultrasafe passive¿ needle guard syringe before use.No injury or medical intervention.

Manufacturer Narrative

The customer issued a complaint for a device which did not lock out during activation detected during production.One sample was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history records review including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels, were manufactured and released according to applicable procedures and specifications.The device could not lock out after activation due to its deformation.We assume that the device received an impact diagonally or asymmetrically or it strained between some machine elements which deformed the guard (parallelogram shape instead of rectangle).Different marks were observed on the two opposite sides of the guard.Some of these marks are supposed to be coming from some machine element, maybe some kind of gripper.The conclusion of the tests indicate that the bd process could not reproduce the marks caused by some machine element (maybe some kind of gripper) which can be seen on the complained device.Based on investigation conclusion, bdm-ps was not able to confirm that the symptom perceived by customer is linked to bdm-ps process.

• Brand Name: X225L BD ULTRASAFE PASSIVE¿ NEEDLE GUARD SYRINGE
• Type of Device: PISTON 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6819013
• MDR Text Key: 83746877
• Report Number: 3009081593-2017-00010
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K011369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 47530630
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other