MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 20X1-1/2 RB; PISTON SYRINGE

Model Number	309579
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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.(b)(4).
Event or Problem Description
It was reported that white foreign matter was found inside the syringe 3ml ll w/ndl 20x1-1/2 rb needle before use.The following information was provided by the initial reporter: "customer has received the following customer complaint for a white.Foreign material found inside the needle 309579, lot 9175481.".
Additional Manufacturer Narrative
H.6.Investigation: two photos displaying a loose standard needle assembly were received and evaluated.It was observed in both photos, the shield was removed, and a large white foreign matter particle was present next to the exposed cannula and shield.The loose particle appeared to be epoxy and was larger than level 3 in size, which was rejectable per product specification.Probable root cause, jam occurred and was not detected in the next process.Based on the investigation and photo sample analysis the defect reported by the customer is confirmed.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.H3 other text : see h.10.
Event or Problem Description
It was reported that white foreign matter was found inside the syringe 3ml ll w/ndl 20x1-1/2 rb needle before use.The following information was provided by the initial reporter: "customer has received the following customer complaint for a white.Foreign material found inside the needle 309579 lot 9175481.".

• Brand Name: SYRINGE 3ML LL W/NDL 20X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10738070
• Report Number: 1213809-2020-00740
• Device Sequence Number: 17051506
• Product Code: FMF
• UDI-Device Identifier: 30382903095798
• UDI-Public: 30382903095798
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 309579
• Device Catalogue Number: 309579
• Device Lot Number: 9175481
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1