MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE

Catalog Number 990173

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 before us it was noticed that bd plastipak¿ syringes had plastic burrs in the syringe.

Event Description

It was reported that before use, seven bd plastipak¿ syringes had plastic burrs in the syringe.

Manufacturer Narrative

Correction: describe event or problem: it was reported that before use, seven bd plastipak¿ syringes had plastic burrs in the syringe.Investigation summary: device history record, quality notification and maintenance records were analyzed and no occurrences potentially related to the defect was observed.Investigation conclusion: the samples sent by the customer were verified and it was possible observe foreign matter ¿ plastic residue.According to the bd foreign matter evaluation procedure, the fm were identified.One sample at level 1, two samples at level 2 and four samples at level 3 in size ranking.Root cause description: the potential root cause for the foreign matter incident is associated with the assembly process.Rationale: the incident identified from this complaint will be monitored for trend evaluation.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8190602
• MDR Text Key: 131319307
• Report Number: 3003916417-2018-00365
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000408
• UDI-Public: 7891463000408
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 990173
• Device Lot Number: 8148780
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other