MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SER PLAS 1ML 13X3,8 U-100 150; SYRINGE

Catalog Number 990147

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the analysis of the batch history (dhr), maintenance records and quality notifications were verified and no deviation was found for this batch.Through the analysis of the sample sent by the customer, it is possible to observe the illegible printed batch, in this way bd confirms the claim.The label review record, which is carried out to ensure correct printing of information, was analyzed and no defects were found.No request for reprinting of labels related to the claimed box was evidenced.Investigation conclusion: the incident identified from this complaint will be monitored for trend assessment.Root cause description: the possible cause for the incident was an entanglement of the box in the part of the equipment that pulls the box for closing.For this occurrence, bd has a project to change the design of the equipment with the change in the box's traction system, with completion forecast for december/2022.

Event Description

It was reported that ser plas 1ml 13x3,8 u-100 150 label was unreadable.The following information was provided by the initial reporter: during the receipt, it was identified the description is unreadable, and some labels are torn.1 box with quality issue (it's unreadable), which it's not possible to identify its id#; 2 boxes with label torn, id#s 0575, and 0603.

• Brand Name: SER PLAS 1ML 13X3,8 U-100 150
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12518858
• MDR Text Key: 272898787
• Report Number: 3003916417-2021-00301
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 990147
• Device Lot Number: 1168929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1