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

Catalog Number 990687

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/05/2019

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 plastipak¿ luer-lok¿ syringe was observed to have no scale markings on it during use.The following information was provided by the initial reporter, translated from portuguese to english: "syringe without graduation.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.No root cause can be determined as no samples were received.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe was observed to have no scale markings on it during use.The following information was provided by the initial reporter, translated from portuguese to english: "syringe without graduation.".

Event Description

It was reported that the bd plastipak¿ luer-lok¿ syringe was observed to have no scale markings on it during use.The following information was provided by the initial reporter, translated from portuguese to english: "syringe without graduation.".

Manufacturer Narrative

H.6.Investigation: dhr, quality notification and maintenance analysis were performed and no occurrences potentially.Related to the defect was observed.The sample sent by the customer was verified and it was possible to observe scale marking issue.The probable cause for the occurrence is related to failure at printing system at the marking machine, allowing the defect product flow of the process.H3 other text : see h.10.

• Brand Name: BD PLASTIPAK LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 9505058
• MDR Text Key: 203532019
• Report Number: 3003916417-2019-00644
• 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,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 990687
• Device Lot Number: 9098512
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 12/05/2019
• Supplement Dates FDA Received: 01/21/2020; 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other