MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿; PISTON SYRINGE

Model Number	309635
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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 with hypodermic needle precisionglide¿ there was a mix of product.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that only syringe in the lot with a red cap.
Additional Manufacturer Narrative
H6: investigation summary: one sealed packaged syringe and one photo of a 5ml luer-lock syringe (p/n 309635) batch 1274106 with red needle attached was received and evaluated.The packaged sample has an 18x1 ½ inch blunt fill needle attached to the syringe in a 20x1 ½ inch package.The condition observed is non-conforming per product specification.Potential root cause for the incorrect needle defect is associated with the assembly process.As a corrective actions, quality deficiency notice was given to a responsible associate for line clearance and quality alert will be issued to the entire plant for awareness.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 with hypodermic needle precisionglide¿ there was a mix of product.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that only syringe in the lot with a red cap.

• Brand Name: BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿
• 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 ; 8015296192
• MDR Report Key: 14141326
• Report Number: 1213809-2022-00211
• Device Sequence Number: 15030539
• Product Code: FMF
• UDI-Device Identifier: 30382903096351
• UDI-Public: 30382903096351
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: 09/30/2026
• Device Model Number: 309635
• Device Catalogue Number: 309635
• Device Lot Number: 1274106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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