MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD GLASPAK¿ SYRINGE, BULK, NON-STERILE; ANESTHESIA SYRINGE

Catalog Number 400671

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/16/2019

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 the bd glaspak¿ syringe, bulk, non-sterile, experienced foreign matter contamination noted prior to use.

Event Description

It was reported that the bd glaspak¿ syringe, bulk, non-sterile, experienced foreign matter contamination noted prior to use.

Manufacturer Narrative

Investigation: a review of the device history record was completed for catalog 400671, lot 7269656 manufactured from october 2017.Was analyzed for the test to verify "damaged component" and no records of this defect were evidenced.There are no quality notification (qn) or nonconformity report of ¿damaged component" that could lead to this complaint for the claimed lot.According to the visual analysis of the attached photo containing the claimed defect, it was found that inside the glass syringe there is a broken syringe tip, confirming the reported defect.Based on the investigation results to date the root cause was not determinate for this complaint.

• Brand Name: BD GLASPAK¿ SYRINGE, BULK, NON-STERILE
• Type of Device: ANESTHESIA SYRINGE
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8320656
• MDR Text Key: 135907191
• Report Number: 9610048-2019-00106
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 400671
• Device Lot Number: 7269656
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other