MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA WINGSET SEZSET 23X.75 12 W/O LUER; INTRAVASCULAR CATHETER

Catalog Number 38733614

Device Problems Break (1069); Leak/Splash (1354); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/24/2020

Event Type  Injury  

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 an unspecified number of wingset sezset 23x.75 12 w/o luer experienced a safety mechanism that would not engage resulting in a dirty needle injury during use.It has not been specified whether medical intervention was administered as a result of the dirty needle stick injury.The following information was provided by the initial reporter: complaint 1 of 2 customer complains that the scalpes when activating the safety devices, this one locks and this caused two drilling work accidents and one of the devices broke.One employee accident case occurred between (b)(6).

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported that an unspecified number of wingset sezset 23x.75 12 w/o luer experienced a safety mechanism that would not engage resulting in a dirty needle injury during use.It has not been specified whether medical intervention was administered as a result of the dirty needle stick injury.The following information was provided by the initial reporter: complaint 1 of 2: customer complains that the scalpes when activating the safety devices, this one locks and this caused two drilling work accidents and one of the devices broke.One employee accident case occurred between (b)(6) september.

Manufacturer Narrative

The following information has been updated/corrected: b.5.Describe event or problem: it was reported that an unspecified number of wingset sezset 23x.75 12 w/o luer experienced a safety mechanism that would not engage and product damage/deformation while still considered operable.The product defects resulted in a dirty needle injury during use.The affected personnel received blood testing after the incident with the results coming back negative.No additional medical intervention was applied.The following information was provided by the initial reporter: complaint 1 of 2.Customer complains that the scalpes when activating the safety devices, this one locks and this caused two drilling work accidents and one of the devices broke.One employee accident case occurred between (b)(6).Description of the event received on 12nov2020: in less than 10 days, two collaborators from the laboratory drilled themselves with scalp 23 from bd.The reason for both accidents was the same "when the safety device was activated, it stopped" one of the scalps came to break a part of the device.The lot of scalps 21, are the same lot: 9275484 exp: set / 24.There was no need for medical intervention for health professionals due to accidents at work (medication administration, etc.).We performed serology for both source patients.Because the results were ¿negative¿ there was no medical or medication intervention; there was exposure of contaminating material to professionals.Both professionals had perforations on their fingers.In both accidents there was blood residue on the scalp needles.B.6.Relevant tests/laboratory data: the affected personnel received blood testing after the incident with the results coming back negative.No additional medical intervention was applied.F.10.Device codes: 2979, 1354, 1069.H.6.Fda device problem code(s): 2979, 1354, 1069.H.6.Fda patient problem code(s): 2462.

Event Description

It was reported that an unspecified number of wingset sezset 23x.75 12 w/o luer experienced a safety mechanism that would not engage and product damage/deformation while still considered operable.The product defects resulted in a dirty needle injury during use.The affected personnel received blood testing after the incident with the results coming back negative.No additional medical intervention was applied.The following information was provided by the initial reporter: complaint 1 of 2.Customer complains that the scalpes when activating the safety devices, this one locks and this caused two drilling work accidents and one of the devices broke.One employee accident case occurred between (b)(6).Description of the event received on 12nov2020: in less than 10 days, two collaborators from the laboratory drilled themselves with scalp 23 from bd.The reason for both accidents was the same "when the safety device was activated, it stopped" one of the scalps came to break a part of the device.The lot of scalps 21, are the same lot: 9275484 exp: set / 24.There was no need for medical intervention for health professionals due to accidents at work (medication administration, etc.).We performed serology for both source patients.Because the results were ¿negative¿ there was no medical or medication intervention; there was exposure of contaminating material to professionals.Both professionals had perforations on their fingers.In both accidents there was blood residue on the scalp needles.

• Brand Name: WINGSET SEZSET 23X.75 12 W/O LUER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 10690803
• MDR Text Key: 211735605
• Report Number: 3003916417-2020-00310
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 38733614
• Device Lot Number: 9275484
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other