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

Catalog Number	305863
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 the bd¿ enteral syringe with clear barrel and bd univia¿ connector had what looks like mold inside the barrel.Found before use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: two opened syringes were returned for complaint review.One syringe had a dust particle inside the syringe but outside the fluid path.The other syringe had a rubber/silicone residue from the rubber stopper inside the syringe fluid path therefore failure mode is verified.Three syringes are mentioned in the complaint, but only two samples were received.No mold was present in either of the two syringes that were provided.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: dust particle: a small piece of dust in the air either fell on an exposed syringe or empty package.Syringes have minimal time exposed to open air, as most of the machines are covered with dust covers to prevent dust from falling on product.Rubber/silicone residue: the rubber residue is from the rubber stopper and was mixed with silicone during the stopper lubing process.No damage was present on the stopper of this syringe sample, so it is unknown where exactly the loose rubber residue came from.
Event or Problem Description
It was reportedthat the bd¿ enteral syringe with clear barrel and bd univia¿ connector had what looks like mold inside the barrel.Found before use.No reports of serious injury or medical intervention noted.

• Brand Name: BD¿ ENTERAL SYRINGE WITH CLEAR BARREL AND BD UNIVIA¿ CONNECTOR
• Common Device Name: ENTERAL/ORAL SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7616381
• Report Number: 1911916-2018-00294
• Device Sequence Number: 13939519
• Product Code: KNT
• UDI-Device Identifier: 00382903058631
• UDI-Public: 00382903058631
• 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: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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 Catalogue Number: 305863
• Device Lot Number: 7282569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/09/2018
• 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