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

Catalog Number	302833
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reported phone #: (b)(6).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 302833 and lot number 8214901.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that there was leakage past the stopper/plunger while using bd 30 ml luer slip syringe.This occurred 8 times, however, no patient impact reported.The following information was provided by the initial reporter, translated from chinese to english: the nurse in charge found fluid leakage at the connection between the syringe and the piston when drawing the normal saline.

• Brand Name: BD 30 ML LUER SLIP SYRINGE
• 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: 14734755
• Report Number: 1911916-2022-00304
• Device Sequence Number: 2426973
• Product Code: FMF
• UDI-Device Identifier: 00382903028337
• UDI-Public: 00382903028337
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K172670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2022

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: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 302833
• Device Lot Number: 8214901
• 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: 05/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• 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