MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE SOLOMED 5ML LL 22X1 W/SH SLA

Catalog Number 302630

Device Problems Complete Blockage (1094); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

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 when using the syringe solomed 5ml ll 22x1 w/sh sla the needle was clogged and leakage past the stopper/plunger.The following information was provided by the initial reporter.The customer stated: "material had a clogged needle, medication returned through the plunger as if the rubber was not tight.No damage to patient occurred.".

Event Description

It was reported when using the syringe solomed 5ml ll 22x1 w/sh sla the needle was clogged and leakage past the stopper/plunger.The following information was provided by the initial reporter.The customer stated: "material had a clogged needle, medication returned through the plunger as if the rubber was not tight.No damage to patient occurred.".

Manufacturer Narrative

H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.

• Brand Name: SYRINGE SOLOMED 5ML LL 22X1 W/SH SLA
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 12436229
• MDR Text Key: 271652293
• Report Number: 3003916417-2021-00248
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302630
• Device Lot Number: 0105468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1