MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE

Catalog Number 300865

Device Problems Leak/Splash (1354); Volume Accuracy Problem (1675)

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

Event Date 08/30/2021

Event Type  malfunction  

Event Description

It was reported that 2 bd plastipak¿ concentric luer lock syringes had damaged barrels that caused leakage, and 1 syringe was missing part of its scale markings.The following information was provided by the initial reporter, translated from french to english: "a new report will follow for 2 syringes showing leaks, this time the fault is on the body of the syringe.We have for one of it used by the pharmacy for a chemotherapy preparation, its batch number: again batch number 2105104.Its packaging has been checked, it is intact and waterproof.Event#1 i noticed for lot # 2105104 that there are syringes packed with invisible graduations (paper side); event#2.Photo received shows the tip damaged so this is an event#4 we are going to report you with the answers.For this 3rd file, the problem encountered is still the presence of leaks, but this time due to defects on the body of the syringes.And not because of the piston seal.For the graduations, i specify that they are indeed present, but for certain syringes on the paper side.And not on the top.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 2 bd plastipak¿ concentric luer lock syringes had damaged barrels that caused leakage, and 1 syringe was missing part of its scale markings.The following information was provided by the initial reporter, translated from french to english: "a new report will follow for 2 syringes showing leaks, this time the fault is on the body of the syringe.We have for one of it used by the pharmacy for a chemotherapy preparation, its batch number: again batch number 2105104.Its packaging has been checked, it is intact and waterproof.Event#1.I noticed for lot # 2105104 that there are syringes packed with invisible graduations (paper side); event#2.Photo received shows the tip damaged so this is an event#4.We are going to report you with the answers.For this 3rd file, the problem encountered is still the presence of leaks, but this time due to defects on the body of the syringes.And not because of the piston seal.For the graduations, i specify that they are indeed present, but for certain syringes on the paper side.And not on the top.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/27/2021.H.6.Investigation: samples and photos received for investigation with reference 300865 and lot number 2105104.Complaint describes four events that will be investigated, the first one is leakage, invisible graduations when the syringe is inside the package, air inside the syringe and tip damage.Upon evaluation, damaged barrel, and cracked barrel near the tip of the syringe can be observed.One of the pictures provided by customer shows leakage past the stopper.In the picture it can be seen a 50ll syringe with damage in the barrel and liquid that have passed the first and second rib of the stopper.Upon observation of the sample, barrel is damaged which caused the leakage.All the syringes were disassembled to examine parts separately.No defects were detected in parts by separate and no molding defects were identified.Stopper were correctly assembled in all the syringes.All the syringes were filled with water and no air was detected in the barrels, air bubbles that enter by the tip when the syringe is filled, can be removed easily.Additionally, one of the syringes shown in pictures is packaged with the scale not visible.The part of the syringe where the scale is printed is not visible when the device is inside the unitary packaging.This is not a defect as syringes can be placed with the scale visible through the packaging or with the scale in the paper side.Orientation of the scale inside the packaging is not a defect caused by a process failure.Possible root cause for damaged barrel is associated with the assembly process where a jam occurred.When syringes are exposed to negative pressure while being used in an electric pump, this type of damage in barrel (dent) could favor the entrance of air through the stopper.This process is being addressed by unit quality and corrective actions will be implemented to reduce the incidence of this defect.Since manufacturing record established that all production and quality processes were carried out normally, we cannot confirm the root cause for cracked barrel.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time for air bubbles and scale making.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• 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: 12535215
• MDR Text Key: 283770289
• Report Number: 3003152976-2021-00636
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2105104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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