MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 22X1-1/2 RB; PISTON SYRINGE

Model Number	309574
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd syringe 3ml ll w/ndl 22x1-1/2 rb contained foreign matter.The following information was provided by the initial reporter: "it was reported that the tip of the needle is contaminated.".
Additional Manufacturer Narrative
H6: investigation summary three photos were received and evaluated.One photo showed a loose 3ml syringe with needle (p/n 309574) and a blisterpak from batch #9008860.Two photos showed the uncapped needle which had a white foreign matter in the fluid path protruding out of the needle tip and leaking onto the bevel.The observed condition was non-conforming per product specification.Potential root cause for foreign matter defect is associated with the needle supplier¿s manufacturing process.The photos were forwarded to the needle supplier for further evaluation and investigation.Further investigation performed at needle supplier site.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Potential root cause for foreign matter defect is associated with assembly line.H3 other text : see h10.
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl 22x1-1/2 rb contained foreign matter.The following information was provided by the initial reporter: "it was reported that the tip of the needle is contaminated.".

• Brand Name: BD SYRINGE 3ML LL W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12960052
• Report Number: 1213809-2021-00801
• Device Sequence Number: 1751105
• Product Code: FMF
• UDI-Device Identifier: 30382903095743
• UDI-Public: 30382903095743
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: 12/31/2023
• Device Model Number: 309574
• Device Catalogue Number: 309574
• Device Lot Number: 9008860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown