MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED¿ SYRINGE WITHOUT NEEDLE

Catalog Number 302665

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: the dhr was performed, maintenance record analysis and quality notification analysis.No samples or photos were sent by the customer not being possible perform an investigation or determine the root cause for the occurrence.The manufacturing process are validated with defined acceptance criteria.From these information¿s it is not possible confirm the complaint.The batch record was verified and the manufacturing date for this batch was march 26th to 29th, 2018.The process inspections were performed at properly frequency and no records of this defect were found.Qn review: no quality notification (qn) that could related to defect were observed.Maintenance review: no maintenance record that could related to defect were observed.Investigation conclusion: complaint status: not confirmed: bd was not able to confirm/ reproduce the incident in question.Samples/ photos analysis: photos were not received from customer for analysis.Root cause description: no samples or photos were sent by the customer not being possible perform an investigation or determine the root cause for the occurrence.Rationale: capa is not required.

Event Description

It was reported that bd solomed¿ syringe without needle exhibited loose closure.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.Evaluating the sample provided by the customer it was possible confirm premature plunger activation.The potential cause for the reported problem is a jam at assembly process, leading to the premature activation.

Event Description

It was reported that bd solomed¿ syringe without needle exhibited loose closure.No serious injury or medical intervention was reported.

• Brand Name: BD SOLOMED¿ SYRINGE WITHOUT NEEDLE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7948867
• MDR Text Key: 123277268
• Report Number: 3003916417-2018-00253
• 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
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 302665
• Device Lot Number: 8057683
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other