MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA INOQULA+ TLA; MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT IVD

Model Number	447213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Device manufacture date: unknown.
Event or Problem Description
It was reported that while using the lid fell.There was no indication of serious injury.
Additional Manufacturer Narrative
H6: investigation summary the customer reported that the gas cylinders which hold the sa shifter cover were no longer supporting the weight of the cover, which resulted in operator injury.The shifter cover struck the operator on the left side of their forehead when the operator was removing dishes from inside the shifter of the instrument.The cover is for the shifter assembly in the sa module.These instruments do not have a bsc, and the cover is more accessible to the operator.The operator did not seek any medical attention and did not feel it warranted notifying their supervisor or management and did not seek any medical treatment.The operator reported that it left a mark but there was no bruising or swelling and it did not break the skin in anyway.The operator told the field service engineer that this issue was not reported to the supervisor but wanted to tell us (bd) so the cover could be repaired as the operator was worried it could harm someone.The cover needs to be lifted to resolve certain instrument errors which introduces a risk to the operator.The gas shocks are designed to hold the cover in the open position, but they were no longer strong enough to support the weight.If the cover is not opened to the full height it can close rapidly and injure the operator.In the instance detailed in this case, the cover did strike the operator but did not cause an injury, however it did cause concern for future issues.The field service engineer replaced the shifter cover gas springs.The system was returned to production after completion of service.This issue was not reportable for serious injury.It is a malfunction.See h10.
Event or Problem Description
It was reported that while using the lid fell.There was no indication of serious injury.

• Brand Name: BD KIESTRA INOQULA+ TLA
• Common Device Name: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT IVD
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11368887
• Report Number: 1119779-2021-00374
• Device Sequence Number: 934175
• Product Code: JTC
• UDI-Device Identifier: 00382904472139
• UDI-Public: 00382904472139
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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 Model Number: 447213
• Device Catalogue Number: 447213
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1