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

Model Number	305853
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 ".
Additional 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 or Problem 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
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12351921
• Report Number: 1213809-2021-00590
• Device Sequence Number: 4496973
• Product Code: KNT
• UDI-Device Identifier: 30382903058533
• UDI-Public: 30382903058533
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/21/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1