MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD TOTALYS SLIDEPREP; SEE H.10

Model Number 491346

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

Common device name: processor, cervical cytology slide, automated.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 while using the bd totalys¿ slideprep instrument patient samples from a batch became misassociated.This incident occurred on (b)(6) 2019 and the customer informed bd on (b)(6) 2020.In (b)(6) 2020, it was discovered that a mix up had taken place in a batch (16 samples).The original surepath vials are marked with the correct social security number, but the material on the glasses in at least 2 cases is mixed up within the batch.This misassociation led to two patients being misdiagnosed with confusion between "suspected squamous cell carcinoma" and "low-grade squamous cell carcinoma".Until the mix-up was discovered, the continued care of the patients was based on the wrong diagnoses.Between "suspected squamous cell carcinoma" and "low-grade squamous cell carcinoma".Until the mix-up was discovered, the continued care of the patients were based on the wrong diagnoses.

Event Description

It was reported that while using the bd totalys¿ slideprep instrument patient samples from a batch became disassociated.This incident occurred on (b)(6) 2019 and the customer informed bd on (b)(6) 2020.In (b)(6) 2020, it was discovered that a mix up had taken place in a batch (16 samples).The original surepath vials are marked with the correct social security number, but the material on the glasses in at least 2 cases is mixed up within the batch.This disassociation led to two patients being misdiagnosed with confusion between "suspected squamous cell carcinoma" and "low-grade squamous cell carcinoma".Until the mix-up was discovered, the continued care of the patients was based on the wrong diagnoses.Between "suspected squamous cell carcinoma" and "low-grade squamous cell carcinoma".

Manufacturer Narrative

H6: investigation summary complaint alleges mis-association of specimen sample on the slideprep instrument serial number (b)(6).The sample mismatch issue was due to operator error when scanning the consumables or placing them in the tray in the multiprocessor or associated slides on the slideprep instrument.Customer notes "it is not possible to investigate if labels have been placed on the wrong vial since the original vials and tubes were discarded already".The customer was unable to reproduce the issue and speculated it was due to workflow error as new staff that has not been trained by bd experts are using the devices.This complaint is not a confirmed failure of the instrument.Root cause is attributed to operator error.The instrument is behaving as intended.Device history record (dhr) review is not necessary as this complaint is unconfirmed and the cause identified.Returned samples are not required for this investigation.Immediate correction was to discuss proper processing with the customer.This was a single and accidental incident.Formal corrective action is not needed.Bd quality will continue to closely monitor trends associated with failure of ¿chain of custody¿.

• Brand Name: BD TOTALYS SLIDEPREP
• Type of Device: SEE H.10
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 10703626
• MDR Text Key: 212299223
• Report Number: 1119779-2020-00738
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904913465
• UDI-Public: 00382904913465
• Combination Product (y/n): N
• PMA/PMN Number: P970018
• 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: 12/14/2020

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?: No
• Device Operator: Other
• Device Model Number: 491346
• Device Catalogue Number: 491346
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 12/12/2020
• Supplement Dates FDA Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other