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

Catalog Number 47450530

Device Problems Leak/Splash (1354); Material Separation (1562); Difficult or Delayed Activation (2577)

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

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Pma/510(k)#: k011369, k122558.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that during use of the ultrasafe x100l png raspberry nvs stein the plunger disconnected and the auto-retractable needle did not engaged.The following information was provided by the initial reporter: the plunger disconnected and the auto-retractable needle wasn't engaged.

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 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.

Event Description

It was reported that during use of the ultrasafe x100l png raspberry nvs stein the plunger disconnected and the auto-retractable needle did not engaged.The following information was provided by the initial reporter: the plunger disconnected and the auto-retractable needle wasn't engaged.

• Brand Name: ULTRASAFE X100L PNG RASPBERRY 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: 9172369
• MDR Text Key: 216636629
• Report Number: 3009081593-2019-00228
• 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: 10/17/2019

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: 01/31/2023
• Device Catalogue Number: 47450530
• Device Lot Number: 8040573
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other