MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Model Number 337146

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs¿ lyse wash assistant leakage of biohazard coming from the instrument was detected.The following information was provided by the initial reporter: "wastebottle/connection is leaking and waste is running onto the waste tank.The connector is plugged in correctly.Is the leak fluid or air? liquid; was the leak contained within the instrument? not contained; was the fluid actively spraying about outside the machine? no; is leaked liquid type known? biohazardous or non-biohazardous? biohazard; did the leaked liquid have bleach mixed in? after waste line; was anyone injured due to the leaked liquid? no.".

Manufacturer Narrative

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.

Manufacturer Narrative

H.6 investigation summary: ¿ 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 waste leakage not contained within the instrument was due to a worn waste tank and connector.The customer called regarding a leaking waste tank (pn 33634907)/ connection (b)(6)) and requested for a connector and waste bottle as replacements to be sent to them.When the parts arrived onsite the customer was able to install the tank onto their instrument without an fse¿s assistance.No parts were requested for evaluation as the waste bottle is not a returnable part and was discarded.After the replacement, the customer confirmed that the instrument was tested and performing as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk of this hazard has been identified to be within the acceptable level.¿ service max review: review of related work order #: n/a, case # (b)(4) install date: (b)(6) 2012 defective part number: 33634907, (b)(6) o subject / reported: 337146 - bd facs lyse wash assistant - wastebottle/connection leaking o problem description: wastebottle/connection is leaking and waste is running onto the waste tank.The connector is plugged in correctly.Case comments: o (5/25/2022 5:10 am) wastebottle/connection is leaking and waste is running onto the waste tank.The connector is plugged in correctly.O (5/25/2022 5:20 am) with customer remained that i send her the connector and the wastebottle in self-exchange, so the problem should be fixed: qty part description ref repaired product info return info abc alternative preceding (b)(6) assem waste bottle serv x06 a 1 (b)(6) 1/8 in pants barb, coupl x06 not returnable a o (5/27/2022 12:35 am) as discussed here is the information on delivery of the lwa waste tank and connector.We have received confirmation that the parts should arrive today and keep our fingers crossed that everything arrives at your hospital on time with the transport service provider and the internal delivery.Order date.: 25/05/22 arrival date.: 27/05/22 o (5/31/2022 6:15 am) 11 delivered (b)(6) - germany 08:18 1 piece o (5/31/2022 6:17 am) customer called to check whether the parts had already arrived at the laboratory and whether she could install/replace them: customer not reached! o (6/1/2022 2:09 am) customer called, 1 (b)(6) assem waste bottle serv x06 a 1 (b)(6) 1/8 in hose barb, coupl x06 not returnable a have arrived, have been exchanged, everything is tight again and the device is running, the case can be closed.¿ returned sample evaluation: a return sample was not requested because the replaced part is not returnable and was discarded.¿ risk analysis: risk management files part # 337146fmea, rev.04/vers.D, lyse wash assistant fmea disinfectant project and part # 347190-lwa-ra rev.04/vers a, bd facs lyse/wash assistant (lwa) system hazards analysis report were reviewed.No new hazards have been identified and the current mitigation is sufficient.Hazard(s) identified? yes no o id: 20.1 o item: bd disinfectant o function: contain the waste o potential failure mode: integrity of waste tank compromised o potential causes: incompatibility of antifoam with pp waste tank material o local and next-level effects: waste leaks out of the tank.O hazards: chemical/biohazard due to incompatible material/chemical reaction o risk controls: disinfectant added to waste tank; samples lysed and/or fixed; anti-foam msds o effectiveness verification: refer to memo: steris vesta syde sq product chemical compatibility with anti-foam and waste tank.O probability: (b)(4) o severity: (b)(4) o risk index: (b)(4) o output: none.O hazard: difficult to use o cause: 2.2.3.1 connector damaged o risk controls: 1.Manufacturing test o final risk: 4b while 4b was chosen, it falls under the minor acceptability level listed in the risk evaluation and acceptability criteria section in page 9 of part # 347190-lwa-ra rev.04/vers a, bd facs lyse/wash assistant (lwa) system hazards analysis report.Mitigation(s) sufficient yes no ¿ root cause: based on the investigation results the root cause of the leakage not contained within the instrument was due to a worn waste tank and connector.¿ conclusion: based on the investigation results, the root cause of the leakage of waste not contained within the instrument was due to a worn waste tank and connector.The customer called regarding the leakage of waste tank/connection and requested for replacement tank and connector to be sent to them.Upon arrival of the parts, the customer successfully installed the waste bottle onto the instrument.After the replacement, the instrument was functioning as expected.No one was harmed or injured, and no medical diagnosis was performed due to the leakage.The safety risk of this hazard has been identified to be within the acceptable level.¿ supporting document: n/a.

Event Description

It was reported that while using bd facs¿ lyse wash assistant leakage of biohazard coming from the instrument was detected.The following information was provided by the initial reporter: "wastebottle/connection is leaking and waste is running onto the waste tank.The connector is plugged in correctly.1.Is the leak fluid or air? liquid; 2.Was the leak contained within the instrument? not contained; 3.Was the fluid actively spraying about outside the machine? no; 4.Is leaked liquid type known? biohazardous or non-biohazardous? biohazard; 5.Did the leaked liquid have bleach mixed in? after waste line; 6.Was anyone injured due to the leaked liquid? no.".

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• 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: 14548329
• MDR Text Key: 293855505
• Report Number: 2916837-2022-00139
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/22/2022

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 Model Number: 337146
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 05/31/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 09/29/2022
• 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