MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPACK¿ SYRINGE

Catalog Number 990172

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 the bd plastipack¿ syringe product came with the stopper bent, making it impossible to be used.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: samples/ photos analysis: a sample was received, and it is possible to observe stopper damaged.Dhr review: it was verified the batch record and the manufacturing date for this batch was november 21th to 22th, 2017.The process inspections were performed at properly frequency and no records of this defect were found.The current controls at manufacturing process to detect the defect are performed by visual inspection with each 2 hours at 36 parts at assembly machine; qn review: no quality notification (qn) that could related to defect were observed.Maintenance review: no maintenance record related to the defect was observed.The probable cause for the defect is related to material jam at syringes assembly machine, causing the stopper defective, allowing the damage product flow of the process.As containment action it was opened the maintenance order sap#(b)(4) to verify the assembly machine.As corrective action it was performed the blitz#57/2018 to damaged components and the actions will be implemented until sep/2018.Investigation conclusion: confirmed: bd was able to confirm/ reproduce the incident in question.Material jam at syringes assembly machine.

• Brand Name: BD PLASTIPACK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7636563
• MDR Text Key: 112449209
• Report Number: 3003916417-2018-00113
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 990172
• Device Lot Number: 8088799
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other