MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSING SOLUTION 10X CONCENTRATE; PRODUCTS, RED-CELL LYSING PRODUCTS

Catalog Number 663518

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/06/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd facs¿ lysing solution 10x concentrate, there was spray of fluid under pressure.The following information was provided by the initial reporter that there was spray of fluid under pressure.Leak checklist from wo: 1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained.3) was there spray of liquid under pressure? yes, sheath liquid during a monthly clean.4) what was the fluid that leaked? non biohazard.5) did biohazard leak before or after waste line? before waste line.6) was the waste mixed with decontamination/bleach? 7) was the customer/bd personnel physically in contact with the fluid? no.

Event Description

It was reported that while using bd facs¿ lysing solution 10x concentrate, there was spray of fluid under pressure.The following information was provided by the initial reporter that there was spray of fluid under pressure.Leak checklist from wo 1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained.3) was there spray of liquid under pressure? yes, sheath liquid during a monthly clean.4) what was the fluid that leaked? non biohazard.5) did biohazard leak before or after waste line? before waste line.6) was the waste mixed with decontamination/bleach? 7) was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

H.6 investigation summary investigation summary: ¿ scope of issue: the scope of issue is only limited to facslyric 3l12c instrument usivd, part # 663518, serial # (b)(6).¿ problem statement: customer reported complaint regarding a spray of fluid.¿ manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 06sep2021 to 06sep2022.¿ complaint trend: this is the only pr related to spray of fluid, pr 6000108.Date range from 06sep2021 to 06sep2022.¿ manufacturing device history record (dhr) review: dhr part #663518 serial # z663518000169, file # 663518-663518-z663518000169-107519819-21, was reviewed.The instrument met all the manufacturing specifications prior to release.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the spray was a damaged fitting causing fluid leak.The customer stated that there was a leak at v9.The field service representative (fsr) confirmed the leak and that there was a spray of sheath fluid during the monthly clean.The fsr replaced the fitting, performed cleans, and performed pqc and abort counts.After performing the replacement, the instrument was performing as intended.While there was a spray of fluid not contained within the instrument, it was not to a degree to significantly increase the risk of contact with the customer.Additionally, the fluid that leaked was sheath fluid and did not come in contact with the customer or bd personnel.The safety risk of this hazard has been identified to be within the acceptable level.As a troubleshoot recommendation, proper daily and monthly cleaning procedures can be found under ¿maintenance¿ also in the bd facslyric¿ clinical system instructions for use, # 23-19938-02 rev.01, vers.A on page 165.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: 02605512, case # 01788052 install date: 02sep2021 defective part number: na work order notes: o subject: leaking from v9 o problem description: leaking from v9 o work performed: replaced fitting, ran monthly clean, daily clean, performed pqc, abort count.No calibrated tools used.O cause: damaged fitting causing fluid leak during monthly clean o solution: fitting was taken from field service trunk stock.¿ returned sample evaluation: a return sample was not requested because part replaced is not returnable and was discarded.¿ risk analysis: risk management file part # 10000063058ra, rev.07/vers.Aa, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? ¿yes ¿no o azure id: 89193 o id: libivd-ra-85 2.2.9 o hazard: exposure to chemicals o cause: failed fluidic connection for sheath.O harmful effects: damage to instrument.O probability: 1 o severity: 3 o risk index: 3 ¿ root cause: based on the investigation results the root cause of the spray was a damaged fitting causing fluid leak.¿ conclusion: based on the investigation results, the root cause of the spray was a damaged fitting causing fluid leak.The fsr replaced the fitting, performed cleans, and performed pqc and abort counts.After performing the replacement, the instrument was performing as intended.¿ supporting document: n/a h3 other text : see h.10.

• Brand Name: BD FACS¿ LYSING SOLUTION 10X CONCENTRATE
• Type of Device: PRODUCTS, RED-CELL LYSING PRODUCTS
• 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: 15404418
• MDR Text Key: 306164599
• Report Number: 2916837-2022-00251
• Device Sequence Number: 1
• Product Code: GGK
• UDI-Device Identifier: 00382906635181
• UDI-Public: 0100382906635181
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 663518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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