MAUDE Adverse Event Report: BECTON DICKINSON BD SYR 2ML LS 24X1 DN BP INDIA; SYRINGE

Catalog Number 303070

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Device evaluated by mfr: 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 there was tip damage and detaches from syringe with a bd syr 2ml ls¿ 24x1 dn bp (b)(6).The following information was provided by the initial reporter: 2ml & 5ml syringe tip gets stuck in 3way stopcock device.And tip gets damaged.Detached from syringe in to the 3way port hub.

Manufacturer Narrative

H.6.Investigation summary: the dhr was reviewed and no ncp or qn was raised on this lot during manufacturing and production of the lot number 18e2581 until lot release.No customer return sample and photograph are available for investigation.The team reviewed the process controls of assembly process and packaging process.All process controls are in place.The team also checked the syringe tip force as measured during the manufacturing of customer reported lot 18e2581 which found within the specification limit there are various factors involved in luer tip damage like dimension luer slip of syringe, tip outer diameter etc.The dimension of barrel tip of retention sample of 2ml emerald syringe 24g are checked and conforms within specification limit, it is also observed that 2ml 24g is not the right product to be used in the three way port hub, for further investigation we will require a practice demonstration video to comment further.The team will monitor the defect during manufacturing and if any such incident occur related to needle separation will take actions appropriately.The exact root cause is not identified due to lack of sample or photographs from the customer.Therefore the customer complaint could not be confirmed for further investigations.

Event Description

It was reported that there was tip damage and detaches from syringe with a bd syr 2ml ls¿ 24x1 dn bp india.The following information was provided by the initial reporter: 2ml & 5ml syringe tip gets stuck in 3way stopcock device.And tip gets damaged.Detached from syringe in to the 3way port hub.

• Brand Name: BD SYR 2ML LS 24X1 DN BP INDIA
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8546049
• MDR Text Key: 147609145
• Report Number: 2243072-2019-00778
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• 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: 303070
• Device Lot Number: 18E2581
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other