MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT III; SEE H10

Model Number 647205

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

Patient Problem Abrasion (1689)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.Medical device expiration date: na.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 the fse scratched his left hand on the needle of the bd facs¿ sample prep assistant iii.Upon arrival needle was cleaned per procedure.Scratch was cleaned and disinfected, fse will contact his personal doctor for consultation.The following information was provided by the initial reporter: the bd field safety engineer was at the customer for a non-emergency repair of the barcode reader of a bd facs¿ sample prep assistant iii.During the repair the fse has scratched his left hand on the spa needle.The instrument is normally used for (b)(6) samples.Upon arrival the needle was cleaned as per normal procedures.Fsa was able to disinfect his hand with soap and disinfectant immediately after the incident.Fse will contact personal doctor for consultation.Fse has scratched his left hand during a non-emergency repair of the barcode reader.Instrument is normally used for (b)(6) samples.Upon arrival needle was clean as result of the normal cleaning procedures of the instrument itself.These cleanings happened with at least 4to5 times a good clean trough with distilled water.Last decontamination with facs clean was on 21/05/2021 according to the information.Fse was able to instantly after the incident disinfect the complete hand with soap and disinfectants.

Manufacturer Narrative

H6: investigation: scope of issue: the scope of issue is limited to part: 647205 spaii and serial number: (b)(6).Problem statement: fse spa needle incident.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months).Complaint trend: this is the only complaint related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months).Investigation result/analysis: per report: the bd field safety engineer was at the customer for a non-emergency repair of the barcode reader of a bd facs¿ sample prep assistant iii.During the repair the fse has scratched his left hand on the spa needle.The instrument is normally used for hiv samples.Upon arrival the needle was cleaned as per normal procedures.Fsa was able to disinfect his hand with soap and disinfectant immediately after the incident.Fse will contact personal doctor for consultation.Service max review: review of related work order #: no work order was initiated.Install date: (b)(6) 2015.Defective part number: n/a.Returned sample evaluation: n/a.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 02 was reviewed.Hazard(s) identified? yes or no.Hazard id: 3.2.32.Hazard: service hazards.Severity: 5.Probability: 1.Risk index: 5.Implementation: bd facs spa service manual pn333917 - bd facs sample prep user¿s guide 23-13406-03.Risk control: alarp.Mitigation(s) sufficient: yes or no.Root cause: based on the investigation result, and the service report the root cause was failure to follow service procedures calling for working with the safety cover up.Conclusion: based on the investigation result, and the service report the fse failed to follow service procedures calling for working with the safety cover up.

Event Description

It was reported that the fse scratched his left hand on the needle of the bd facs¿ sample prep assistant iii.Upon arrival needle was cleaned per procedure.Scratch was cleaned and disinfected, fse will contact his personal doctor for consultation.The following information was provided by the initial reporter: the bd field safety engineer was at the customer for a non-emergency repair of the barcode reader of a bd facs¿ sample prep assistant iii.During the repair the fse has scratched his left hand on the spa needle.The instrument is normally used for hiv samples.Upon arrival the needle was cleaned as per normal procedures.Fsa was able to disinfect his hand with soap and disinfectant immediately after the incident.Fse will contact personal doctor for consultation.Fse has scratched his left hand during a non-emergency repair of the barcode reader.Instrument is normally used for hiv samples.Upon arrival needle was clean as result of the normal cleaning procedures of the instrument itself.These cleansings happened with at least 4to5 times a good clean trough with distilled water.Last decontamination with facs clean was on (b)(6) 2021 according to the information.Fse was able to instantly after the incident disinfect the complete hand with soap and disinfectants.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT III
• Type of Device: SEE H10
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 12010557
• MDR Text Key: 265814825
• Report Number: 2916837-2021-00279
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: K131301
• 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: 08/04/2021

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other