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 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Pma/5019k)#: k011369, 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 experienced a broken syringe/pen during use.The following information was provided by the initial reporter: when he went to pull the medication out of the package the plunger popped up and he heard it click.The patient stated that he tried to administer the injection in his leg and he then felt fluid going down his leg, and the needle never came out.The patient stated that he went to pull back off leg the little case that retracts when done the whole piece fell out.

Event Description

It was reported that the ultrasafe x100l png clear nvs stein experienced a broken syringe/pen during use.The following information was provided by the initial reporter: when he went to pull the medication out of the package the plunger popped up and he heard it click.The patient stated that he tried to administer the injection in his leg and he then felt fluid going down his leg, and the needle never came out.The patient stated that he went to pull back off leg the little case that retracts when done the whole piece fell out.

Manufacturer Narrative

H.6.Investigation: 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.H3 other text : see h.10.

• 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: 9153240
• MDR Text Key: 216639775
• Report Number: 3009081593-2019-00226
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K011369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 47439230
• Device Lot Number: 8128662
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other