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

Catalog Number 990175

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 a bd plastipak¿ syringe luer-lok¿ had a damaged stopper prior to use.

Manufacturer Narrative

Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The sample received was evaluated and submitted to validated test and no deviation were observed.Based on sample evaluation and tests performed it was not possible confirm the complaint.Thus it is not possible confirm the defect of this complaint was related of bd process.

Event Description

It was reported that a bd plastipak¿ syringe luer-lok¿ had a damaged stopper prior to use.

Manufacturer Narrative

The corrections are as follows: it was included that the device experienced leakage during use in addition to the previously reported stopper damage.

Event Description

It was reported that a bd plastipak¿ syringe luer-lok¿ had a damaged stopper prior to use.

• Brand Name: BD PLASTIPAK¿ SYRINGE LUER-LOK¿
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8206256
• MDR Text Key: 131914385
• Report Number: 3003916417-2018-00371
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463001771
• UDI-Public: 7891463001771
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 990175
• Device Lot Number: 7270820
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other