MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 302579

Device Problem Material Separation (1562)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd syringe with needle the stopper separated from the plunger.This is report 1 of 2.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: to finish, i will attach 1 photo after the incident occurred today, and i will attach about 3 more where we have had failures with the plunger and 1 failure with the presence of liquid in the syringe without even having opened it.

Manufacturer Narrative

One hundred samples and four photos received by our quality team for investigation 96 from lot 2136079, three from lot 1299636, and one from lot 0226073.Through visual inspection, it can be observed that 86 syringes are lubricated with appears to be an excessive amount of silicone, and stopper separation from plunger is observed on two syringes.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Lubricant is employed during the syringe assembly process to lubricate the cylinders in the silicone station.The silicone employed in this product is a medical grade silicone authorized for product use.Silicone content tests are performed during the manufacturing process of each lot number.Quantification of silicone performed were not within specification.Possible root cause for excessive silicone is associated with damage to the silicone valve.Possible root cause for stopper separation is associated with manufacturing personnel.Manufacturing personnel have been trained and notified of this incident.Cleaning of the silicone dispensing nozzles will take place.

Event Description

Additional information received.To finish, i will attach 1 photo after the incident occurred today, and i will attach about 3 more where we have had failures with the plunger and 1 failure with the presence of liquid in the syringe without even having opened it.Could you detail the specific failure that occurs in the piston? for example broken, poorly adjusted, does not provide vacuum, etc.It is not broken but it was disembedded from the plunger, that is, when pulling it, they separated.Could you detail the specific failure that occurs in the piston? for example broken, poorly adjusted, does not provide vacuum, etc.It is not broken but it was disembedded from the plunger, that is, when pulling it, they separated.Is the piston belt that occurred on the same day as the needle leak belt, are they from the same lot and reference? no, with reference to the piston failure there are 2 syringes with 2 different lots (lot: 2098925 cad: 03/2027 and lot: 2136079 cad: 03/2027).And with reference to the escape strip of the needle (which i understand is with reference to the other syringe) its data is lot: 2221167 and cad: 07/2027.

• Brand Name: BD SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17476662
• MDR Text Key: 320871206
• Report Number: 9614033-2023-00076
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

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: 302579
• Device Lot Number: 2098925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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