MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BBL¿ GRAM IODINE (STABILIZED); DIAGNOSTIC STAINS & REAGENTS

Model Number	212542
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Test Result (2695)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
The customer reported that while using bd bbl¿ gram iodine (stabilized) they noticed large cocci like artifact and clumping in the stain.The artifact and clumping obscured the reading of a synovial gram stain which lead to erroneous results being reported by the technician.The technician reported the erroneous gram stain result to the clinician and the patient underwent an unnecessary surgical procedure.
Additional Manufacturer Narrative
H.6.Investigation summary no returns received.A retention sample from the complaint batch was evaluated along with a control batch.The solution appearance was satisfactory and comparable to the control; both were a dark brown solution.Staining was completed per instructions in the product insert.Slides of e.Coli atcc 25922 and s.Aureus atcc 25923 controls were evaluated and had satisfactory staining results with the retention and control batches.No excessive artifact was seen.The retention sample was comparable to the control.The batch history record was reviewed and no discrepancies were found.All release testing was satisfactory.Complaint trends were reviewed for a period covering 12 months.During that time there have been no other complaints on this batch.H3 other text : see section h.10.
Event or Problem Description
The customer reported that while using bd bbl¿ gram iodine (stabilized) they noticed large cocci like artifact and clumping in the stain.The artifact and clumping obscured the reading of a synovial gram stain which lead to erroneous results being reported by the technician.The technician reported the erroneous gram stain result to the clinician and the patient underwent an unnecessary surgical procedure.

• Brand Name: BD BBL¿ GRAM IODINE (STABILIZED)
• Common Device Name: DIAGNOSTIC STAINS & REAGENTS
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• MDR Report Key: 9812223
• Report Number: 1119779-2020-00004
• Device Sequence Number: 778269
• Product Code: JTS
• UDI-Device Identifier: 00382902125426
• UDI-Public: 00382902125426
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 212542
• Device Catalogue Number: 212542
• Device Lot Number: 9296675
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other