MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED¿ SYRINGE WITH NEEDLE

Catalog Number 302631

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

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

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(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 during use of the bd solomed¿ syringe with needle when pulling the plunger in order to aspirate the medicine, the plunger releases, leaving the stopper inside the syringe.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: confirmed: bd was able to confirm/ reproduce the incident in question.Samples/ photos analysis: evaluation of the returned sample showed plunger activation.Dhr review: the batch record and the manufacturing date for this batch was march 25th to 28th, 2017.The process inspections were performed and no records of this defect were found.The current controls at manufacturing process to detect the defect are performed by visual inspection each hour at 36 samples at assembly machine and activated plunger rejection system challenge each shift.Qn review: no quality notification (qn) that could related to defect were observed.Maintenance review: no maintenance records that could be related to the defect were observed.Conclusion: a dhr was performed, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.Evaluating the complaint description and sample provided by the customer it was possible observe plunger activation.The potential cause for the reported problem is a jam at assembly process.The defect identified from this complaint will be monitored for trend evaluation.

• Brand Name: BD SOLOMED¿ SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7245372
• MDR Text Key: 99789994
• Report Number: 3003916417-2018-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• 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: 302631
• Device Lot Number: 7054824
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other