MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5ML SYRINGE WITH PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number	309634
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 5ml syringe with precisionglide¿ needle had foreign matter inside.This was discovered during use.The following information was provided by the initial reporter: material no: 309634 batch no: 8294971.It was reported that there was some sort of contaminant inside of sterile syringe.Per customer email: one of our locations just reported finding a contaminant in a sterile syringe she opened.
Additional Manufacturer Narrative
Investigation: four photos and one loose 5ml barrel with an opened blister pack from batch 8294971 (p/n 309634) were received and evaluated.There was also a white gauze present with some black residue.No visual defects were observed on the syringe barrel.Based on the initial notification of the complaint, it appeared the gauze was used to clean out the syringe barrel.The initial location of the black residue is unclear, and the sample was sent for fourier transform infrared (ftir) spectroscopy for further analysis.It was determined the black residue was most likely grease used to lubricate machine components.Potential root cause for the foreign matter defect is associated with the assembly process.The original location of the foreign matter could not be determined based on the evidence provided so the most likely root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that 5ml syringe with precisionglide¿ needle had foreign matter inside.This was discovered during use.The following information was provided by the initial reporter: material no: 309634 batch no: 8294971.It was reported that there was some sort of contaminant inside of sterile syringe.Per customer email: one of our locations just reported finding a contaminant in a sterile syringe she opened.

• Brand Name: 5ML SYRINGE WITH PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9186085
• Report Number: 1213809-2019-01033
• Device Sequence Number: 14097930
• Product Code: FMF
• UDI-Device Identifier: 30382903096344
• UDI-Public: 30382903096344
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/20/2019

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: 09/30/2023
• Device Catalogue Number: 309634
• Device Lot Number: 8294971
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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