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	10/24/2019
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
It was reported that prior to use mold was discovered inside packaging with a bd syringe 60ml s/t latex free configure.The following information was provided by the initial reporter: it was reported that mold was inside the packaging.
Event or Problem Description
It was reported that prior to use mold was discovered inside packaging with a bd syringe 60ml s/t latex free configure.The following information was provided by the initial reporter: it was reported that mold was inside the packaging.
Additional Manufacturer Narrative
The following field has been updated with additional information: date of event: (b)(6) 2019.
Additional Manufacturer Narrative
Investigation summary: one sample and two photos were provided by the customer for investigation.The sample was visually examined using unaided vision.It was observed that there is brown foreign matter (fm) embedded in the flange of the barrel.As the customer reported mold the fm was tested for mold by the bd lab in columbus with the results coming back negative for mold.Two photos were also provided by the customer for investigation.One photo shows the top web of a blister pack showing the product description and product number.The second photo shows the syringe flange in the blister pack.There is brown foreign matter (fm) which can be seen on the flange of the barrel.Embedded fm can occur at the startup of the injection molding process.Solidified resin within the mold and molding press may become discolored or degraded when reheated.This is a cosmetic defect and does not affect the integrity of the syringe.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.
Event or Problem Description
It was reported that prior to use mold was discovered inside packaging with a bd syringe 60ml s/t latex free configure.The following information was provided by the initial reporter: it was reported that mold was inside the packaging.

• 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: 9304318
• Report Number: 1911916-2019-01181
• Device Sequence Number: 2133309
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2019

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: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 10/25/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/09/2019; 12/10/2019
• 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