MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSDUET SAMPLE PREP

Catalog Number 662588

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that there was a needlestick injury during use with a bd facsduet¿ sample prep.The following information was provided by the initial reporter: needle stick injury.At the time of the event fse was working in close proximity to the probe, which hadn't been moved sufficiently far away.Fse briefly caught his hand on the probe as he worked near by.

Event Description

It was reported that there was a needlestick injury during use with a bd facsduet¿ sample prep.The following information was provided by the initial reporter: needle stick injury.At the time of the event fse was working in close proximity to the probe, which hadn't been moved sufficiently far away.Fse briefly caught his hand on the probe as he worked near by.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part 662588 facsduet and s/n: (b)(6).Problem statement: fse caught his hand on the probe while performing a scheduled pm service on the facsduet on 13feb2020.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 13feb2019 to date 13feb2020 (rolling 12 months).Related qn(s) number: (b)(4).Complaint trend: this is the only complaint related to the reported complaint.Date range (date of incident to 12 months back) from 13feb2019 to date 13feb2020 (rolling 12 months).Manufacturing device history record (dhr) review: review of dhr for pn662588 serial number: (b)(6) was reviewed.Date of manufacture: 24may2019.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review the fse did not follow established safety instructions per bd facsduet service manual doc.No 10000423011 rev 01 (chapter 1, pg 7) prior to performing the pm service.Service max review: review of related work order #: (b)(4).Install date: 12sep2019.Defective part number: no parts were replaced during the pm.Work order notes: subject / reported: this was a scheduled pm service, problem description: n/a, cause: fse failed to follow established safety instructions per bd facsduet service manual doc.No 10000423011 rev 01 (chapter 1, pg 7), work performed: scheduled pm, solution: n/a.Returned sample evaluation: no request was made because there were no defective parts.Risk analysis: risk management file part #10000225098, revision ver h was reviewed.Hazard(s) identified? yes, no.If no (to above), what actions will be taken? hazard id : 1.4.12.Hazard: operator gets cut due to laceration (exposure to sharp edges).Severity: 3.Probability: 1.Risk index: 3.Implementation: nemko safety test iec61010-01 risk control: the system is designed to isolate and protect the user from safety hazards when access points are open.New hazard: mitigation(s) sufficient: yes, no.Root cause: based on the investigation result, the root cause was determined to be fse failed to follow established safety instructions per bd facsduet service manual doc.No 10000423011 rev 01 (chapter 1, pg 7).Conclusion: based on the investigation results, complaint was confirmed.

• Brand Name: BD FACSDUET SAMPLE PREP
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10136168
• MDR Text Key: 194608882
• Report Number: 2916837-2020-00024
• Device Sequence Number: 1
• Product Code: JQW
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 662588
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention