MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE WITH PRECISIONGLIDE¿ NEEDLE; PISTON SYRINGE

Catalog Number	306619
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd syringe with precisionglide¿ needle was clogged.The following was received from the initial reporter: product concern.Syringe won't push forward.
Additional Manufacturer Narrative
Investigation closed 9/27 and reopened 10/9 for a sample return - therefore the awareness date for the investigation closure was updated to 31oct2023 km.(b)(4) follow up for device evaluation.It was reported the syringe would not push forward.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then connected to a syringe with saline solution.The solution expelled with a normal flow.Previous investigations have revealed that process variations during the needle lubricant application process could create clogged needles.The syringe was sent to the manufacturing site for investigation.A visual inspection was performed and there were no defects observed that would contribute to the needle clogged / blocked defect.There is sufficient silicone inside of the barrel.When exercising the plunger there is smooth motion with no interruption.A device history record review was completed for provided material number 306619, lot 2236328.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Several quality initiatives have been implemented on our manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
(b)(4) additional information received.Mat#: 306619, batch#:2236328.It was reported by the customer that syringe won't push forward.Verbatim: rcc received the complaint via email.Mfr reorder # 192-(b)(6).Product name syr/ndl, sfty 192-(b)(6) org3cc 25gx1." lot / serial number: (b)(6).Product concern: syringe won't push forward.

• Brand Name: BD SYRINGE WITH PRECISIONGLIDE¿ NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17686094
• Report Number: 1911916-2023-00631
• Device Sequence Number: 19485167
• Product Code: FMF
• UDI-Device Identifier: 10612479262741
• UDI-Public: 10612479262741
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: Health Professional
• Device Catalogue Number: 306619
• Device Lot Number: 2236328
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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