MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE B100L NG GREEN BULK AMG; PISTON SYRINGE

Catalog Number 47436630

Device Problems Misconnection (1399); Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2019

Event Type  malfunction  

Manufacturer Narrative

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 ultrasafe b100l ng green bulk amg has been found experiencing inability to deliver medication and difficulty to operate before use.The following has been provided by the initial reporter: syringe was locked so medication could not be dispensed.

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.

Event Description

It has been reported that one ultrasafe b100l ng green bulk amg has been found experiencing inability to deliver medication and difficulty to operate before use.The following has been provided by the initial reporter: syringe was locked so medication could not be dispensed.

• Brand Name: ULTRASAFE B100L NG GREEN BULK AMG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 8976220
• MDR Text Key: 216632170
• Report Number: 3009081593-2019-00203
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K972878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

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: 09/30/2021
• Device Catalogue Number: 47436630
• Device Lot Number: 7283010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other