MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SER PLASTIPAK 10ML S LS; SYRINGE

Catalog Number 990558

Device Problems Melted (1385); Material Deformation (2976)

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

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of ser plastipak 10ml s ls experienced stopper deformation.The following information was reporter by the initial reporter: "melted plunger".Information received by email on 4/8/2019: the material and batch numbers is unknown because the package and the product was discarded.The problem was noticed after the use.Information received by email on 4/11/2019: there was no damage.There was no need for intervention.There was no exposure of blood to the skin.The drug used was not informed.

Manufacturer Narrative

Investigation summary: the batch number is unknown, due to that batch history analysis (dhr), maintenance records and quality notifications could not be performed.Photos were sent for evaluation, however it was not possible to carry out an investigation and determine the root cause for the incident.The production processes are validated according to the defined acceptance criteria.The incident identified from this complaint will be monitored for trend evaluation.

Event Description

It was reported that an unspecified number of ser plastipak 10ml s ls experienced stopper deformation.The following information was reporter by the initial reporter: "melted plunger".Information received by email on 4/8/2019: the material and batch numbers is unknown because the package and the product was discarded.The problem was noticed after the use.Information received by email on 4/11/2019: there was no damage.There was no need for intervention.There was no exposure of blood to the skin.The drug used was not informed.

• Brand Name: SER PLASTIPAK 10ML S LS
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8541959
• MDR Text Key: 145517206
• Report Number: 3003916417-2019-00211
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990558
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other