MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK ¿ SYRINGE; PISTON SYRINGE

Catalog Number 302579

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/08/2023

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 that 2 of the bd plastipak ¿ syringe's had loose plungers.The following was received by the initial reporter: hospitalization service makes the return of the referenced product when noticing at the time of its opening that "both syringes have a loose plunger, so the syringe is defective".

Manufacturer Narrative

Photos received by our quality team for investigation.Through visual inspection, two plungers are displayed, the plunger appears defective, it is incomplete.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.Based on the teams investigation, possible root cause is associated with line clearance in molding machines.Manufacturing personnel have been notified and additional training to reinforce proper assembly has been performed.

Event Description

Hospitalization service makes the return of the referenced product when noticing at the time of its opening that "both syringes have a loose plunger, so the syringe is defective".Reason for which quality claim is managed.

• Brand Name: BD PLASTIPAK ¿ SYRINGE
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17585709
• MDR Text Key: 321656998
• Report Number: 9614033-2023-00084
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

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: 2136079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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