MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. WINGSET SEZSET 21X.75 12 W/O LUER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 38734614

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the safety mechanism on the wingset sezset 21x.75 12 w/o luer was difficult to activate during use.This occurred with 30 different wingset devices.The following information was provided by the initial reporter, translated from (b)(6) to english: "safety device with difficult activation of the protection device."inefficient", increasing the risk of an accident compared to the b.Braun model, needle without cutting making it difficult to puncture and increasing interferences with loss of access and causing pain to patients.".

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0027157, and no quality issues were found during production.Our quality engineer reviewed the provided photo but could not identify the reported issue based off the photos.Since no defect could be found a definitive root cause could not be established.H3 other text : see h.10.

Event Description

It was reported that the safety mechanism on the wingset sezset 21x.75 12 w/o luer was difficult to activate during use.This occurred with 30 different wingset devices.The following information was provided by the initial reporter, translated from portuguese to english: "safety device with difficult activation of the protection device."inefficient", increasing the risk of an accident compared to the b.Braun model, needle without cutting making it difficult to puncture and increasing intercurrences with loss of access and causing pain to patients.".

• Brand Name: WINGSET SEZSET 21X.75 12 W/O LUER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10624179
• MDR Text Key: 211010047
• Report Number: 9610048-2020-00139
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38734614
• Device Lot Number: 0027157
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other