MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD CONVENTIONAL SYRINGE; PISTON SYRINGE

Catalog Number 300629

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using the bd conventional syringe the liquid leaked past the plunger.The following was received by the initial reporter: verbatim: it is unknown how many syringes are affected.When drawing up a drug to be given to a patient, when the syringe is turned upside down, the liquid leaks past the plunger down the handle.

Manufacturer Narrative

One photo was provided to our quality team for investigation.Through visual inspection, a leakage past the stopper ribs was observed.There was no other damage or defects that could be identified within the photo that could have contributed to the leak reported.A device history review was performed for the reported lot 2211103, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, including leakage testing.Ten retained samples of lot 2211103 were used for additional evaluation.The product was visually inspected, no defects or damage was noted, the stoppers were verified to be properly assembled on to the plunger rod, and no leak was identified.Based on our investigation, we cannot identify a definitive root cause at this time.

Event Description

It was reported while using the bd conventional syringe the liquid leaked pas the plunger.The following was received by the initial reporter: verbatim: it is unknown how many syringes are affected.When drawing up a drug to be given to a patient, when the syringe is turned upside down, the liquid leaks past the plunger down the handle.

• Brand Name: BD CONVENTIONAL SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17435581
• MDR Text Key: 320155698
• Report Number: 3002682307-2023-00220
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300629
• Device Lot Number: 2211103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1