MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 10ML SYRINGE SLIP TIP

Catalog Number 990558

Device Problem Positioning Problem (3009)

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 the plunger did not slide properly with a bd plastipak¿ 10ml syringe slip tip.The following information was provided by the initial reporter, translated from (b)(6) to english: at the time of use of the syringe with pump they do not slide properly, being in many cases "locked" for the pump to "interpret" that i have already administered the whole solution and this generates inconveniences in the treatment, wasted 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 the plunger did not slide properly with a bd plastipak¿ 10ml syringe slip tip.The following information was provided by the initial reporter, translated from spanish to english: at the time of use of the syringe with pump they do not slide properly, being in many cases "locked" for the pump to "interpret" that i have already administered the whole solution and this generates inconveniences in the treatment, wasted medication, etc.

• Brand Name: BD PLASTIPAK 10ML SYRINGE SLIP TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8537326
• MDR Text Key: 146513703
• Report Number: 3003916417-2019-00208
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 990558
• Device Lot Number: 8177936
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other