MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE 10ML LUER-LOK¿

Catalog Number 990172

Device Problem Gas/Air Leak (2946)

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

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7362760; medical device expiration date: 2022-12-31; device manufacture date: 2017-12-28; medical device lot #: 7362762; medical device expiration date: 2022-12-31; device manufacture date: 2017-12-28; medical device lot #: 7362764; medical device expiration date: 2022-12-31; device manufacture date: 2017-12-28.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ syringe 10ml luer-lok¿ leaked, allowing air bubbles to enter the syringe while drawing blood.No serious injury or medical intervention was reported.

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.

Event Description

It was reported that bd plastipak syringe 10ml luer-lok leaked, allowing air bubbles to enter the syringe while drawing blood.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: device history record, quality notification and maintenance analysis were carried out and no quality occurrences were observed.All the production processes are validated according to established criteria to the fulfillment of the users¿ requirements.According to the internal bd procedures for the situation, a research process was initiated involving bd brazil and united states team in order to evaluate the potential causes for the occurrence of the reported defect.As part of this process were opened a corrective and preventative action and situation analysis and are being several activities for a depth analysis of the problem and understanding of their potential causes.Capa #331654 and situation analysis sa #18-1223.According the investigation, the potential cause to this problem is related to deformity at syringe tip due the production process of the material in molding step.Investigation of the problem will include the following evaluations: ¿ development of an analytical method to measure the tip circumference deformation with accuracy; ¿ include in product draft a specification as to the tip circumference to be monitored during the manufacturing process; ¿ parameters and mold changes to guarantee the product specification changes in order to correct tip deformity.

Event Description

It was reported that bd plastipak¿ syringe 10ml luer-lok¿ leaked, allowing air bubbles to enter the syringe while drawing blood.No serious injury or medical intervention was reported.

• Brand Name: BD PLASTIPAK¿ SYRINGE 10ML LUER-LOK¿
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7776686
• MDR Text Key: 117016296
• Report Number: 3003916417-2018-00201
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000378
• UDI-Public: 7891463000378
• 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,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990172
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other