MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD 3ML SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

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

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that an unspecified number of an unspecified bd 3ml syringe experienced leakage during use.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.Verbatim: one ongoing issue at our facilities over the last few months (minimum) is leaking with their 1ml and 3ml bd syringe infusions in the nicu.Nurses report that when they move the infusion to another pump the leaking does not occur.We have reported this to customer advocacy but have been unable to solve or identify the issue.

Manufacturer Narrative

Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that an unspecified number of an unspecified bd 3ml syringe experienced leakage during use.The following information was provided by the initial reporter: material no.: unknown.Batch no.: unknown.Verbatim: one ongoing issue at our facilties over the last few months (minimum) is leaking with their 1ml and 3ml bd syringe infusions in the nicu.Nurses report that when they move the infusion to another pump the leaking does not occur.We have reported this to customer advocacy but have been unable to solve or identify the issue.

• Brand Name: UNSPECIFIED BD 3ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9512263
• MDR Text Key: 177852937
• Report Number: 2243072-2019-02884
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other