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

Catalog Number 47451130

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528)

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

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the ultrasafe plus x100l png clear there was an issue with leakage.The cap was difficult to remove and when removed the product ran out of the cannula with out the piston being pushed.The following information was provided by the initial reporter: patient returned 1¨prolia syringe to the pharmacy: needle safety cap hardly removable, could only be removed with huge power, when cap was removed, product ran out via the cannula.According to the pharmacist, the patient did not touch the piston while trying to remove the needle safety cap.No application possible.

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.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.During the years of investigation of complaints about pre-activated devices several root causes were discovered which were within the customer¿s sphere of influence.

Event Description

It was reported that before use of the ultrasafe plus x100l png clear there was an issue with leakage.The cap was difficult to remove and when removed the product ran out of the cannula with out the piston being pushed.The following information was provided by the initial reporter: patient returned 1¨prolia syringe to the pharmacy: needle safety cap hardly removable, could only be removed with huge power, when cap was removed, product ran out via the cannula.According to the pharmacist, the patient did not touch the piston while trying to remove the needle safety cap.No application possible.

• Brand Name: ULTRASAFE PLUS X100L PNG CLEAR
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 9377480
• MDR Text Key: 219387156
• Report Number: 3009081593-2019-00267
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 47451130
• Device Lot Number: 9136532
• Date Manufacturer Received: 11/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other