MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE SOLOMED 5ML LL 22X1-1/4 W/SH SLA; PISTON SYRINGE

Catalog Number 302631

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

"date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).".

Event Description

It was reported that an unspecified number of syringe solomed 5ml ll 22x1-1/4 w/sh sla were found to be damaged during use.The following was reported by the initial reporter: "uses injection medication weekly.At least the last syringes purchased, all of them have presented issues.Medication used: betamethasone dipropionate + betamethasone disodium phosphate - eurofarma.".

Event Description

It was reported that an unspecified number of syringe solomed 5ml ll 22x1-1/4 w/sh sla were found to be damaged during use.The following was reported by the initial reporter: "uses injection medication weekly.At least the last syringes purchased, all of them have presented issues.Medication used: betamethasone dipropionate + betamethasone disodium phosphate - eurofarma".

Manufacturer Narrative

H.6.Investigation: dhr could not be performed due to unknown lot#.No samples were returned so an investigation could not be performed.The root cause could not be determined and complaint is unconfirmed.The production processes are validated according to the defined acceptance criteria.In this way confirmation of the claim is not possible.Validated tests are performed for the activation force of the plunger during the release of the batches produced as a means of control.See h.10.

• Brand Name: SYRINGE SOLOMED 5ML LL 22X1-1/4 W/SH SLA
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 11362601
• MDR Text Key: 259580483
• Report Number: 3003916417-2021-00038
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 302631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1