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

Catalog Number 47439230

Device Problem Failure to Deliver (2338)

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

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: 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; g.5.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.

Event Description

It was reported that the ultrasafe x100l png clear nvs stein needle failed to inject a small amount of cosentx into the patient's leg during use.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter, "the patient advised that she did her first subcutaneous injection of cosentx and thought the plunger would not go in any more however when she removed the needle from her leg there was a very small amount of drug not injected.".

Event Description

It was reported that the ultrasafe x100l png clear nvs stein needle failed to inject a small amount of cosentx into the patient's leg during use.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "the patient advised that she did her first subcutaneous injection of cosentx and thought the plunger would not go in any more however when she removed the needle from her leg there was a very small amount of drug not injected.".

Manufacturer Narrative

Investigation summary: 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 tatabánya 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: 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: 8874196
• MDR Text Key: 215133786
• Report Number: 3009081593-2019-00189
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 47439230
• Device Lot Number: 7117213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other