MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE X100L PNG CLEAR NVS STEIN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 47439230

Device Problems Break (1069); Difficult or Delayed Activation (2577)

Patient Problem No Patient Involvement (2645)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8312560, medical device expiration date: 2023-10-31, device manufacture date: 2018-11-08.Medical device lot #: 8206727, medical device expiration date: 2023-06-30, device manufacture date: 2018-07-25.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a ultrasafe x100l png clear nvs stein had a damaged safety device during use.The following was reported by the initial reporter: "syringe damage".This case is about a prematurely activated safety device, the picture was provided to us.On the picture it can be detected that one of the two clips is strongly bent.".

• Brand Name: ULTRASAFE X100L PNG CLEAR NVS STEIN
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer (Section G): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11244028
• MDR Text Key: 258006725
• Report Number: 3009081593-2021-00005
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 47439230
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1