MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 50ML; PISTON SYRINGE

Catalog Number 300865

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 syringe 50ml broke, causing leakage.The following information was provided by the initial reporter: ".1 doxorubicin syringe where the top of the syringe and.Attachment had snapped off resulting in a leak".

Manufacturer Narrative

H6: investigation summary: photo received for investigation.Upon visual inspection a 50ll syringe with the tip broken is observed.The syringe is kept in a bag with another device with a female luer lok.Complaint describes the tip of the syringe snapped off when it was being used with another device, causing leakage by the broken part.Information and picture provided suggest this defect was caused by an overscrew of the syringe with the female luer lok device.An overscrew of the syringe may lead to breakage of the tip.Additionally, ten retained samples from the same lot were inspected, no damages or issues found.A device history review was performed for lot 2005269, 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 tip and thread verification testing.All results were reviewed for lot 2005269 and found to be within specification.Based on our investigation and given the device records did not identify any failures related to this incident, we are not able to determine a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.

Event Description

It was reported syringe 50ml broke, causing leakage.The following information was provided by the initial reporter: ".1 doxorubicin syringe where the top of the syringe and.Attachment had snapped off resulting in a leak.".

• Brand Name: SYRINGE 50ML
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12595787
• MDR Text Key: 275393083
• Report Number: 3003152976-2021-00670
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

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
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2005269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• 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