MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 20ML SYRINGE LUER SLIP

Catalog Number 990173

Device Problem Unintended Movement (3026)

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

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 during use of the bd plastipak¿ 20ml syringe luer slip when the syringe is used with a pump it does not slide properly, it gets stuck.There were 3000 occurrences.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: when the 20 ml ls plastipak syringe is used with a pump, it does not slide properly, it gets stuck, so the pump "interprets" that the medication was already being administered causing disruption in treatment, wasting medication, etc.

Manufacturer Narrative

It was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the incident were observed.We inform that validated tests for products usage are performed, but none of them predicts bomb infusions interaction.Without physical samples, it is not possible evaluate the defect and determine the root cause.This way, it is not possible to confirm the incident of this complaint was related of bd process.

Event Description

It was reported that during use of the bd plastipak¿ 20ml syringe luer slip when the syringe is used with a pump it does not slide properly, it gets stuck.There were 3000 occurrences.Foreign complaint the following information was provided by the initial reporter, translated from spanish to english: when the 20 ml ls plastipak syringe is used with a pump, it does not slide properly, it gets stuck, so the pump "interprets" that the medication was already being administered causing disruption in treatment, wasting medication, etc.

• Brand Name: BD PLASTIPAK 20ML SYRINGE LUER SLIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8551869
• MDR Text Key: 146514800
• Report Number: 3003916417-2019-00213
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000408
• UDI-Public: 7891463000408
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 990173
• Device Lot Number: 7054589
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other