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

Catalog Number 47450030

Device Problem Failure to Deliver (2338)

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

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

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 has been reported that one bd¿ ultrasafe x100l png clear secure tab has been found blocked during use.The following has been provided by the initial reporter: according to the complaint description, the nurse was unable to inject the solution, of tevagrastim 30miu/0.5ml since the syringe was blocked.The box was intact, she doesn't know if the security system has been pre-activated.

Event Description

It has been reported that one bd¿ ultrasafe x100l png clear secure tab has been found blocked during use.The following has been provided by the initial reporter: according to the complaint description, the nurse was unable to inject the solution, of tevagrastim 30miu/0.5ml since the syringe was blocked.The box was intact, she doesn't know if the security system has been pre-activated.

Manufacturer Narrative

Investigation summary: sample and photos were 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.The safety device is activated and decontaminated.One of the trigger fingers of the guard is bent.The trigger finger covers of the body and the syringe capture features of body do not seem to be bent or damaged.Based on the sample there is damage on the safety device which could explain premature releasing of the unit.36 retained samples were examined and no completely or partially activated devices were found.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.

• Brand Name: BD ULTRASAFE X100L PNG CLEAR SECURE TAB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 9417337
• MDR Text Key: 216670426
• Report Number: 3009081593-2019-00273
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 47450030
• Device Lot Number: 7223166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other