MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 60ML S/T LATEX FREE CONFIGURE; PISTON SYRINGE

Catalog Number	309654
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Material no.: 309654 batch no.: 9133518.It was reported that before use of the bd syringe 60ml s/t latex free configure there is a mold-like substance found on item inside of package.The following information was provided by the initial reporter: possible mold on item package is wrapped.
Event or Problem Description
Material no.: 309654, batch no.: 9133518.It was reported that before use of the bd syringe 60ml s/t latex free configure there is a mold-like substance found on item inside of package.The following information was provided by the initial reporter: possible mold on item package is wrapped.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed.Based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed.Therefore, a potential root cause(s) cannot be determined.Bd performs bioburden testing once every three (3) months for each product family.This testing includes testing for mold.Monthly environmental testing is also performed in the production area.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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.H3 other text : see section h.10.

• Brand Name: BD SYRINGE 60ML S/T LATEX FREE CONFIGURE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9312218
• Report Number: 1911916-2019-01197
• Device Sequence Number: 2245985
• Product Code: FMF
• UDI-Device Identifier: 30382903096542
• UDI-Public: 30382903096542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (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): 11/26/2019

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: 04/30/2024
• Device Catalogue Number: 309654
• Device Lot Number: 9133518
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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