MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR; GASTROINTESTINAL TUBE

Catalog Number	305863
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 there was foreign matter "some type of fungus" found on the top of a bd¿ enteral syringe with clear barrel and bd univia¿ connector.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported there was foreign matter "some type of fungus" found on the top of a bd¿ enteral syringe with clear barrel and bd univia¿ connector.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
Additional Manufacturer Narrative
Investigation summary: a review of the device history record indicates there was no documentation of issues identified during production of complaint batch 7282566.One (1) sample was received.A visual inspection was performed and it was concluded the sample had a build-up of foreign matter particulates-dust on the tip of the stopper.A visual inspection of the returned sample appears to be polypropylene particulates/dust.A review of the batch record did not indicate any issues during production of the complaint batch.Additionally, all required cleaning was performed at the defined frequencies.Investigation conclusion: a visual inspection of the returned sample appears to be polypropylene particulates/dust that builds up on/in different areas of the equipment during production.The equipment is cleaned multiple times each day, however, it is possible for a ¿cluster¿ of the particulates to remain on the equipment and break loose later during production.
Event or Problem Description
It was reported there was foreign matter "some type of fungus" found on the top of a bd¿ enteral syringe with clear barrel and bd univia¿ connector.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR
• Common Device Name: GASTROINTESTINAL TUBE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7455186
• Report Number: 1911916-2018-00156
• Device Sequence Number: 1252543
• Product Code: KNT
• UDI-Device Identifier: 30382903058632
• UDI-Public: 30382903058632
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2018

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: 11/30/2022
• Device Catalogue Number: 305863
• Device Lot Number: 7282566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Initial Date Received by Manufacturer: 03/30/2018
• Supplement Date Received by Manufacturer: 03/30/2018; 03/30/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 07/31/2018; 10/02/2018
• 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