MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE WITH LUER SLIP

Catalog Number 990173

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(b)(6).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 incorrect product was boxed with the bd plastipak¿ syringes with luer slips.There was no report of exposure, injury, or medical intervention.

Event Description

It was reported that incorrect product was boxed with the bd plastipak syringes with luer slips.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Manufacturer Narrative

Investigation summary: the dhr, quality notifications and maintenance records were analyzed.It was possible confirm the defect of product mix in view of the origin of the label and product information of both batches.Through the points evaluated during the flow of the process it was found that one of the failures was for the operation in looping during the sorting or separation of the boxes and as the box in question was not read by the sensor, the same went to the area of rejects and the operator ended up positioning the box with divergent label in the lot of 20ml ll - 8057778.As a corrective action will be performed a new training with sterilization operators reinforcing the some activities related to sorting operations.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that incorrect product was boxed with the bd plastipak¿ syringes with luer slips.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD PLASTIPAK¿ SYRINGE WITH LUER SLIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7813259
• MDR Text Key: 118396927
• Report Number: 3003916417-2018-00212
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 990173
• Device Lot Number: 7362886
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other