MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 21X1 RB; PISTON SYRINGE

Model Number	309575
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 while using bd syringe 3ml ll w/ndl 21x1 rb the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: details of complaint (reported issue): we have received our shipment, but during inspection one of the batches of 3cc syringes failed inspection.Complaint category: fail to function / defective.Incident date: (b)(6) 2023.Complaint noticed: prior to use.Problem frequency: 1st time.Customer exposure: patient injury: no.Qty affected: 3 ca.Samples available? yes.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-jun-2023 h6: investigation summary four samples and one photo were provided to our quality team for investigation.Through visual inspection, it was observed that all syringes have an excessive ink ring around the barrel extending from 1 and 1/2ml area to 3ml area.Potential root cause for the ink rings defect is associated with the marking process.These defects are occurring below an expected rate so no corrective actions will be made at this time.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
Event or Problem Description
It was reported while using bd syringe 3ml ll w/ndl 21x1 rb the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: details of complaint (reported issue): we have received our shipment, but during inspection one of the batches of 3cc syringes failed inspection complaint category: fail to function / defective incident date: 08 jun 2023 complaint noticed: prior to use problem frequency: 1st time customer exposure: patient injury: no.Qty affected: 3 ca.Samples available? yes.

• Brand Name: BD SYRINGE 3ML LL W/NDL 21X1 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17239273
• Report Number: 1213809-2023-00684
• Device Sequence Number: 7207140
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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 Model Number: 309575
• Device Catalogue Number: 309575
• Device Lot Number: 2188392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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