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

Catalog Number 990558

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 05/15/2019

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 that an unspecified number of ser plastipak 10ml s ls experienced a defective/damaged stopper during use.The following information was provided by the initial reporter: information received by email: there was no damage to the patient/health professional, but there was a leakage and lose of the medicament that soiled the patient and the professional.There was no need for medical or surgical intervention.There was no exposure of blood or chemotherapy to the skin.The hospital used narcotic drugs.

Event Description

It was reported that an unspecified number of ser plastipak 10ml s ls experienced a defective/damaged stopper during use.The following information was provided by the initial reporter: information received by email: there was no damage to the patient/health professional, but there was a leakage and lose of the medicament that soiled the patient and the professional.There was no need for medical or surgical intervention.There was no exposure of blood or chemotherapic to the skin.The hospital used narcotic drugs.

Manufacturer Narrative

H.6.Investigation: batch history analysis, quality notifications and maintenance records were reviewed and records were found potentially related to the occurrence.The available image was analyzed, and it was possible to observe the stopper with mounting failure.The probable cause for the incident is related to failure in the cork stopper station.H3 other text : see h.10.

• 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: 8705874
• MDR Text Key: 149224131
• Report Number: 3003916417-2019-00289
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 990558
• Device Lot Number: 8225643
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other