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 Patient Involvement (2645)

Event Date 08/20/2020

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.(b)(4).

Event Description

It was reported that waste leakage occurred outside of instrument during use with a bd facs¿ lyse wash assistant.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer reports that he has noticed a leak under the instrument.Upon opening the instrument he noticed that the washing liquid is not drained.The leakage was not contained within the instrument.The leakage was in a customer accessible location.The leaked fluid was waste, not mixed to bleach.The source of the leak was a waste line.Liquid was not sprayed.Customer was not exposed to blood or bodily fluids.The customer suffered no physical harm as result of the leak.

Manufacturer Narrative

H6: investigation summary: scope of issue: the scope of issue is only limited to part # 337146 and serial # (b)(6).Problem statement: customer reported complaint on a bd facs lyse wash assistant ¿ 337146 of waste leakage without bleach not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 20aug2019 to date 20aug2020.Complaint trend: there are 4 complaints related to this issue of waste leakage without bleach not contained within the instrument.Pr #s (b)(4).Date range from 20aug2019 to date 20aug2020.Manufacturing device history record (dhr) review: dhr part # 337146 serial # (b)(6), file # (b)(4), 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, and risk analysis, the root cause of the waste leakage not contained within the facs lyse wash assistant was due to a clogged/blocked barbed fitting, part# 34350807.This issue was confirmed by the fse (field service engineer) as there was no drainage from the cell wash assembly, causing leakage.After the repair, the instrument was draining normally with no further leakage.This part was from non-inventoried stock and was discarded.No return sample was requested for evaluation because it is not a returnable part.Although the leak was waste and the potential exposure to biohazard material, there was no skin contact nor was there any medical treatment performed.No user was harmed or injured.Users are cautioned to wear proper ppe (personal protective equipment), especially handling the cell wash station and biohazardous waste, in the bd facs lyse wash assistant user¿s guide.H3 other text : see h.10.

Event Description

It was reported that waste leakage occurred outside of instrument during use with a bd facs¿ lyse wash assistant.The following information was provided by the initial reporter, translated from italian to english: the customer reports that he has noticed a leak under the instrument.Upon opening the instrument he noticed that the washing liquid is not drained.The leakage was not contained within the instrument.The leakage was in a customer accessible location.The leaked fluid was waste, not mixed to bleach.The source of the leak was a waste line.Liquid was not sprayed.Customer was not exposed to blood or bodily fluids.The customer suffered no physical harm as result of the leak.

• 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
• MDR Report Key: 10507790
• MDR Text Key: 241762308
• Report Number: 2916837-2020-00114
• Device Sequence Number: 1
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/09/2020

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
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other