MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML CLEAR STERILE; GASTROINTESTINAL TUBE AND ACCESSORIES

Model Number 305853

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default 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 was reported that syringe oral 3ml clear sterile was received expired.The following information was provided by the initial reporter: " it was reported expired product ".

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# (b)(4) was sent in error.This record is being cancelled as this is not a bd issue.

Event Description

It was reported that syringe oral 3ml clear sterile was received expired.The following information was provided by the initial reporter: "it was reported expired product".

• Brand Name: SYRINGE ORAL 3ML CLEAR STERILE
• Type of Device: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12351921
• MDR Text Key: 267623444
• Report Number: 1213809-2021-00590
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30382903058533
• UDI-Public: 30382903058533
• Combination Product (y/n): N
• PMA/PMN Number: K112434
• 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: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 305853
• Device Catalogue Number: 305853
• Device Lot Number: 6152689
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1