MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART; COUNTER, DIFFERENTIAL CELL

Model Number 338962

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

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 during use with the bd facscanto¿ ii system w/fluidics cart that leakage of biohazard occurred outside of the instrument.The following information was provided by the initial reporter: it was reported by the customer that there is leakage in 2 places in the system.Leak checklist: was the leak liquid or air? (if liquid/ both, go to question #2.If air, no further questions required.): liquid.Was the leak contained within the instrument? (if not contained, go to question #3.If contained, no further questions required.): not contained.Was there spray of liquid? (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.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/ unknown, go to question #5): biohazard.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): after waste line.Was the waste mixed with decontaminate/bleach? (if no, go to question #7.If yes, no further questions required.): no.Was the customer/ bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact included: clothing, skin, mucous membrane, inhalation, and non-intact skin.): no.

Manufacturer Narrative

H.6 investigation summary scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2/2 sys ivd, part # 338962 and serial # (b)(6).Problem statement: customer reported complaint regarding leakage in the system on (b)(6) 2023.This poses the risk of harming or injuring the customer or patient due to contact with the fluid.The instrument was repaired and found to be functioning as expected, and neither the customer nor any patients were harmed due to this issue.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from (b)(6) 2022 to (b)(6) 2023.¿ device history record (dhr) review: dhr part # 338962 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.¿ complaint history review: there are 443 complaints related to as reported code 1 : fluidic ¿ leak.Then further filtered by as analyzed code 1, as analyzed code 2 and as analyzed component there are 48 complaints.Date range from (b)(6) 2022 to (b)(6) 2023.The complaint history report is attached to trackwise.¿ returned sample analysis: a return sample was not requested because part replaced is not returnable.¿ service history review: review of related work order #: (b)(4), case # (b)(4) install date: (b)(6) 2014 defective part number: n/a work order notes: o subject / reported: leakage at 2 places in the system o problem description: leakage at 2 places in the system o work performed: inspected instrument and the wet cart; no leak was coming from the instrument.Found a cracked fitting on the waste line that the customer installed between the wet cart and their floor drain.Replaced the cracked fitting with a spare the customer had on hands.Tested the fluidics by performing multiple prime after refill and fluidic startup sequence.Ran cst and it pass.Instrument is fully operational and ready for customer samples.Notified the customer that bd should not be responsible for their custom waste solution.O cause: cracked fitting on customer's custom waste solution.O solution: replaced the cracked fitting with a spare the customer had on hands.O parts replaced: n/a ¿ labeling / packaging review: n/a ¿ risk analysis: risk management file part #338942ra, rev.09/vers.H, bd facscanto product family risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no ¿ id: 3.1.12 ¿ hazard: potential leakage ¿ cause: potential lack of workmanship during assembly ¿ harmful effects: potential biohazard exposure ¿ residual probability: 1 ¿ residual severity: 4 ¿ residual risk index: 4 ¿ potential causes: based on the investigation results, the potential cause was determined to be a cracked fitting.¿ investigation result / analysis: the investigation was performed and based on the review of complaint trend, defect trend, dhr review, risk analysis, and service activity review, the potential cause of the leakage was determined to be a cracked fitting.The customer reported a complaint regarding a leakage at 2 places in the system.The field service representative (fsr) inspected the instrument and the wet cart.The fsr noted that there was no leak coming from the instrument.The fsr confirmed that there was a cracked fitting on the waste line that the customer installed between the wet cart and their floor drain.The fsr proceeded to replace the cracked fitting with a spare that the customer had.The fsr also notified the customer that bd would not be responsible for their custom waste solution.After performing the replacement, the fsr tested the fluidics by performing multiples primes after refill and fluidic startup sequence.The instrument was tested and was confirmed to be fully operational.Although the leak was waste and there was a potential for exposure to biohazard material, there was no skin contact nor was there any medical treatment performed.No user was harmed or injured due to this issue.Bd facscanto ii instructions for use (ifu), #23-20269-00 rev.1/vers.A, indicates to wear suitable protective clothing and gloves to prevent transmission of potential fatal disease from biological specimens.This can be found on page 147 in cleaning the surfaces.¿ conclusion: based on the investigation results, the complaint was confirmed, and the potential cause of the leakage was determined to be a cracked fitting.The customer reported a complaint regarding a leakage at 2 places in the system.The fsr confirmed that there was a cracked fitting on the waste line that the customer installed between the wet cart and their floor drain.The fsr proceeded to replace the cracked fitting with a spare that the customer had.After the replacement, the instrument was tested and was confirmed to be fully operational.Based on the investigation results a capa is not required because the issue was resolved and there was no impact to customer and patient health or safety.¿ supporting document: n/a h3 other text : see h.10.

Event Description

It was reported that during use with the bd facscanto¿ ii system w/fluidics cart that leakage of biohazard occurred outside of the instrument.The following information was provided by the initial reporter: it was reported by the customer that there is leakage in 2 places in the system.Leak checklist: 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, go to question #3.If contained, no further questions required.): not contained 3.Was there spray of liquid? (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): after waste line 6.Was the waste mixed with decontaminate/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, go to question #8.If no, no further questions required.) physical contact included: clothing, skin, mucous membrane, inhalation, and non-intact skin.): no.

• Brand Name: BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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: 16294915
• MDR Text Key: 309499812
• Report Number: 2916837-2023-00027
• Device Sequence Number: 1
• Product Code: OYE
• UDI-Device Identifier: 00382903389629
• UDI-Public: (01)00382903389629
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K141468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338962
• Device Catalogue Number: 338962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• 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