MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 30ML SYRINGE LUER-LOCK TIP; PISTON SYRINGE

Catalog Number	309650
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd 30ml syringe luer-lock tip leaked past the plunger during use.The following information was provided by the initial reporter: "cleanroom technician notified operation supervisors about the incidents of leaking 30 cc.The leak was between the plunger seal and barrel of becton, dickinson 30 cc syringes.".
Additional Manufacturer Narrative
The customer provided updated information that the reported product had not been used, and the original complaint information was misprinted.Therefore, the mdr will be cancelled.
Event or Problem Description
It was reported that the bd 30ml syringe luer-lock tip leaked past the plunger during use.The following information was provided by the initial reporter: "cleanroom technician notified operation supervisors about the incidents of leaking 30 cc.The leak was between the plunger seal and barrel of becton, dickinson 30 cc syringes.".

• Brand Name: BD 30ML SYRINGE LUER-LOCK TIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16375879
• Report Number: 1911916-2023-00071
• Device Sequence Number: 14838574
• Product Code: FMF
• UDI-Device Identifier: 00382903096503
• UDI-Public: 00382903096503
• 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): 04/26/2023

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 Catalogue Number: 309650
• Device Lot Number: UNKNOWN
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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