MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD ALCOHOL BLEND RINSE; GENERAL PURPOSE REAGENT

Model Number	491457
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the label information on bd alcohol blend rinse says there is 30% isopropanol and 30% ethanol.Sds states 50% propanol, 48% ethanol and 2% methanol.The following information was provided by the initial reporter: reported by (b)(6).The label on bd alcohol blend bottle says 30% isopropanol and 30% ethanol which is different from sds.Lot# 1053763 sds states: 2-propanol 50% ethanol 48% methanol 2%.
Additional Manufacturer Narrative
H6: investigation: the bd alcohol blend rinse 1.7l fill is a reagent grade alcohol solution (e.G., methanol, ethanol, isopropanol) intended to be used to dehydrate in the process of biological tissue or clinical specimen.The bd alcohol blend rinse 1.7l fill material number 491457, lot number 1053763 are bulk filled on the groninger, and manually packed at the mebane north carolina facility.Per no.: 491457 title: dhr bd alcohol blend rinse 1.7l fill.The problem reported on the bd alcohol blend rinse 1.7l fill material number 491457, lot number 1053763 was the label on bd alcohol blend bottle says 30% isopropanol and 30% ethanol which is different from sds.Lot# 1053763.The manufacturing batch history record was examined for bd alcohol blend rinse 1.7l fill material number 491457, lot number 1053763 and showed no discrepancy-related issues that can be correlated to this complaint for lot number 1053763.All qc and functional testing for bd alcohol blend rinse 1.7l fill material number 491457, lot number 1053763.A retain inspection was not conducted for bd alcohol blend rinse 1.7l fill material number 491457, lot number 1053763, due to the nature of the complaint.There was one photo provided for visual observation.The photo provided showed the bd alcohol blend rinse 1.7l fill material number 491457, lot number 1053763 with the isopropanol >30 and ethanol >30 circled.The information is accurate on both the label and the the sds (safety data sheet).The information provided on the sds is more specific with the certificate of analysis requirements, which read ethanol 47.2-48%, isopropanol: 49.5-50% and methanol: 2.1-2.6% specification, therefore no label error has occurred, and this complaint event is not confirmed.Complaint history check: a complaint history check was conducted and revealed there were no other complaints against for bd alcohol blend rinse 1.7l fill material number 491457, lot number 1053763.Bd will continue to monitor, and trends related to product performance.
Event or Problem Description
It was reported that the label information on bd alcohol blend rinse says there is 30% isopropanol and 30% ethanol.Sds states 50% propanol, 48% ethanol and 2% methanol.The following information was provided by the initial reporter: reported by cas, bs.The label on bd alcohol blend bottle says 30% isopropanol and 30% ethanol which is different from sds.Lot# 1053763 sds states: 2-propanol 50%; ethanol 48%; methanol 2%.

• Brand Name: BD ALCOHOL BLEND RINSE
• Common Device Name: GENERAL PURPOSE REAGENT
• Manufacturer (Section D): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• MDR Report Key: 12178134
• Report Number: 3008007472-2021-00002
• Device Sequence Number: 12113165
• Product Code: PPM
• UDI-Device Identifier: 00382904914578
• UDI-Public: 00382904914578
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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
• Operator of Device: Other
• Device Expiration Date: 02/05/2024
• Device Model Number: 491457
• Device Catalogue Number: 491457
• Device Lot Number: 1053763
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1