MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ ORAL/ENTERAL DISPENSING CLEAR STERILE SYRINGE; ORAL SYRINGE

Catalog Number	302837
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd¿ oral/enteral dispensing clear sterile syringe leaked during use.There was no report of exposure, injury or medical interventions.
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received in (b)(4) plant for evaluation therefore failure mode could not be verified and root cause could not be determined.A device history record review found no non-conformance associated with this issue during production of this batch.Investigation conclusion: no photos or samples were received in the columbus plant for evaluation therefore failure mode could not be verified and root cause could not be determined.

• Brand Name: BD¿ ORAL/ENTERAL DISPENSING CLEAR STERILE SYRINGE
• Common Device Name: ORAL SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7201900
• Report Number: 1911916-2017-00409
• Device Sequence Number: 984184
• Product Code: KNT
• UDI-Device Identifier: 30382903028376
• UDI-Public: 30382903028376
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 302837
• Device Lot Number: 7109543
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other