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

Catalog Number 47439230

Device Problem Material Separation (1562)

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

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: unconfirmed, no issue observed.Investigation conclusion : the customer issued a complaint for plunger pulled out from the syringe and detached syringe 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.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.Bd ifu which was provided to our customer is detailed enough to avoid mishandling during removal of the combination product from blister or during preparation of the product for administration.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.Root cause description: 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.Bd ifu which was provided to our customer is detailed enough to avoid mishandling during removal of the combination product from blister or during preparation of the product for administration.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.Based on the photos no damage or deformation can be seen on the device which would make it sensitive to syringe unclipping.The flange of the syringe seem to be intact, not broken.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

It was reported that the plunger of a bd¿ ultrasafe x100l png clear nvs stein was found outside syringe body, and safety needle was separated from syringe.Customer¿s verbatim: ¿plunger has been found outside syringe body.Syringe and needle safety device not clipped".

• Brand Name: BD ULTRASAFE X100L PNG CLEAR NVS STEIN
• Type of Device: SYRINGE AN NEEDLE
• 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 ; 8015652341
• MDR Report Key: 8462240
• MDR Text Key: 140316927
• Report Number: 3009081593-2019-00122
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K011369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 47439230
• Device Lot Number: 7117213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• 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