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

Catalog Number 47439230

Device Problem Material Separation (1562)

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

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the plunger separated from the ultrasafe x100l png clear nvs stein before use.The following information was provided by the initial reporter: "patient stated her last syringe top, where you push medication came off".

Manufacturer Narrative

Investigation summary: neither sample nor photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Batch is unknown.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.

Event Description

It was reported that the plunger separated from the ultrasafe x100l png clear nvs stein before use.The following information was provided by the initial reporter: "patient stated her last syringe top, where you push medication came off ".

• Brand Name: ULTRASAFE X100L PNG CLEAR NVS STEIN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 8529113
• MDR Text Key: 142518946
• Report Number: 3009081593-2019-00134
• 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: 05/02/2019

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: Lay User/Patient
• Device Catalogue Number: 47439230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 04/03/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other