MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD 10ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 309604

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

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 that a damaged barrel occurred during use with a bd 10ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, "just following up with you on the situation with the holes in the luer lock 10cc syringes.We have had 2 more cases of that same exact reference # and lot # squirting on our workers.Today, we actually had one go towards the neck and on the face shield of a teammate who was putting on a patient.I have currently just went in and switched all of those syringes out of all stick packs awaiting to be used for patients and thrown them away.Is there any way we can get another case to replace the ones i had to throw away? we have not seen any other issues from any other lot # or reference # syringes." 1 of 2 complaints.

Manufacturer Narrative

H.6.Investigation: 75 samples received for investigation.Samples were evaluated and tested for leakage, and molding defects on the barrel, plunger, and stopper.During the leakage test, the samples were filled with water to their maximum capacity, during this process, no damage was detected in the syringe body that could cause leakage problems, in addition, the samples analyzed visually, showed no component defects that could cause the loss of functionality.There were no defects observed.Furthermore, the lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.No non-conforming part that could be attributable to the defect reported by the client was presented.No deviations (quality notifications) were reported during the manufacturing process.H3 other text : see h.10.

Event Description

It was reported that a damaged barrel occurred during use with a bd 10ml syringe luer-lok¿ tip.The following information was provided by the initial reporter."just following up with you on the situation with the holes in the luer lock 10cc syringes.We have had 2 more cases of that same exact reference # and lot # squirting on our workers.Today, we actually had one go towards the neck and on the face shield of a teammate who was putting on a patient.I have currently just went in and switched all of those syringes out of all stick packs awaiting to be used for patients and thrown them away.Is there any way we can get another case to replace the ones i had to throw away? we have not seen any other issues from any other lot # or reference # syringes." 1 of 2 complaints.

• Brand Name: BD 10ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 9520465
• MDR Text Key: 193914009
• Report Number: 9614033-2019-00298
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096047
• UDI-Public: 30382903096047
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 309604
• Device Catalogue Number: 309604
• Device Lot Number: 9021709
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other