MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

"unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.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 an unspecified bd syringe was damaged before use.The following was reported by the initial reporter: "it was reported that syringes bend.Verbatim: patient complained the bd flextouch syringes bend.Patient ended the call before any additional information could be obtained.Submitting for review.".

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.H3 other text : see h10.

Event Description

It was reported that an unspecified bd syringe was damaged before use.The following was reported by the initial reporter: "it was reported that syringes bend.Verbatim: patient complained the bd flextouch syringes bend.Patient ended the call before any additional information could be obtained.Submitting for review.".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11680598
• MDR Text Key: 246051923
• Report Number: 2243072-2021-01184
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1