MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT II; STATION, PIPPETTING DILUTING CLINICAL

Catalog Number 337170

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs sample prep assistant ii leakage of biohazard coming from the instrument was detected.The following information was provided by the initial reporter: was the leak liquid or air? if liquid/both, go to question.If air, no further questions required.Liquid.Was the leak contained within the instrument? if not contained, got to question.If contained, no further questions required.Not contained.Was there spray of liquid under pressure? if yes, describe the liquid that sprayed then go to question.If no, type ¿no¿ in the text box then go to question.No.What was the fluid that leaked? if non biohazard, no further questions required.If biohazard/unknown, go to question.Biohazard.Did biohazard leak before or after waste line: if before waste line or unknown, go to question.If after waste line, go to question.Unknown.Was the waste mixed with decontamination/bleach? if no, go to question.If yes, no further questions required.No.Was the customer/bd personnel physically in contact with the fluid? if yes, got to question.If no, no further questions required.Physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.No.Blood leaking out.

Manufacturer Narrative

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 while using bd facs sample prep assistant ii leakage of biohazard coming from the instrument was detected.The following information was provided by the initial reporter: "1.Was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.2.Was the leak contained within the instrument? (if not contained, got to question #3.If contained, no further questions required.): not contained.3.Was there spray of liquid under pressure? (if yes, describe the liquid that sprayed then go to question #7.If no, type ¿no¿ in the text box then go to question #4): no.4.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): biohazard.5.Did biohazard leak before or after waste line: (if before waste line or unknown, go to question #7.If after waste line, go to question #6): unknown.6.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.): no.7.Was the customer/bd personnel physically in contact with the fluid? (if yes, got to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no.Blood leaking out.".

Manufacturer Narrative

H6: investigation summary: ¿ scope of issue: the scope of issue is limited to part: 337170 spaii and serial number: (b)(6).¿ problem statement: customer reported: blood leaking out.¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 01may2021 to date 01may2022 (rolling 12 months).¿ complaint trend: there are 8 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 01may2021 to date 01may2022 (rolling 12 months).¿ investigation result / analysis: per fse report: repair/troubleshooting performed: feed through fitting partially blocked, replaced same, checked alignment, all fine, instrument suitable for use.O sample preparation was not affected.There was no delay in patient treatment due to any unexpected results.¿ service max review: review of related work order# (b)(4).Install date: 10aug2006.Defective part number: 640587-coupling body shutoff valve.Work order notes: subject / reported: blood leaking out, problem description: clogged valves, cause: defective inline valves, work performed: replaced coupling valves, solution: replaced coupling valves.¿ returned sample evaluation: return of defective part not required for analysis.¿ manufacturing device history record (dhr) review: review of the dhr for serial number: t0146 and pn337170 was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes/no.Hazard id: 3.1.29 _.Hazard: environmental biohazard.Severity: 5.Probability: 1.Risk index: 5.Implementation: bd facs sample prep user¿s guide__.Risk control: afap.Mitigation(s) sufficient: yes/no.¿ root cause: based on the investigation result and the fse¿s report the root cause was a clogged inline coupling valves.¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for blood leaking out.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk is limited, s2, and there was no impact to the patient health or safety.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT II
• Type of Device: STATION, PIPPETTING DILUTING CLINICAL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14431834
• MDR Text Key: 292057610
• Report Number: 2916837-2022-00127
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 337170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1