MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 5ML LS 23GA 1-1/4IN TW

Catalog Number 302131

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 03/14/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that syringe 3ml ls 23g 1-1/4in tw had molding defects.This was discovered during use.The following information was provided by the initial reporter: without smoothly cutting edge.

Event Description

It was reported that syringe 5ml ls 23ga 1-1/4in tw had molding defects.This was discovered during use.The following information was provided by the initial reporter: without smoothly cutting edge.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-04-21.H.6.Investigation summary three photos and one actual sample were received by our quality team for evaluation.Upon visual inspection slight flashes on the plunger rib were observed; therefore, the incident could be verified.A device history record could not be evaluated as the lot number is unknown.The sample was subjected to flashes and mismatch measurement and the product is within product specification; therefore, a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Manufacturer Narrative

The following fields have been updated with corrections: b.5.Describe event or problem: the event description has been updated with a new medical device brand name.D.1.Medical device brand name: syringe 5ml ls 23ga 1-1/4in tw.D.2.Medical device catalog #: 302131.D.4.Unique identifier (udi) #: (b)(4).D.10.Device available for eval? no.

Event Description

It was reported that syringe 5ml ls 23ga 1-1/4in tw had molding defects.This was discovered during use.The following information was provided by the initial reporter: without smoothly cutting edge.

• Brand Name: SYRINGE 5ML LS 23GA 1-1/4IN TW
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9953702
• MDR Text Key: 189477953
• Report Number: 8041187-2020-00204
• 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,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302131
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other