MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® LUER SLIP TIP SYRINGE STERILE; PISTON SYRINGE

Catalog Number	309659
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using thebd® luer slip tip syringe sterile there were volume accuracy issues.The following was received by the initial reporter: customer called in to report that when administering medication to patient they are noticing that there is still medication left in the barrel afterwards.Issue was noticed last week sometime.
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 that while using thebd® luer slip tip syringe sterile there were volume accuracy issues.The following was received by the initial reporter: customer called in to report that when administering medication to patient they are noticing that there is still medication left in the barrel afterwards.Issue was noticed last week sometime.
Additional Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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 h10.

• Brand Name: BD® LUER SLIP TIP SYRINGE STERILE
• 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: 17569221
• Report Number: 1213809-2023-00879
• Device Sequence Number: 8267477
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 309659
• Device Lot Number: 2336605
• 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: 08/03/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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