MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD KIESTRA INOQULA; UNKNOWN

Model Number	447202
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd kiestra inoqula the cover is slamming shut and a tech got hurt while working on the barcoda.Per customer the lock is malfunctioning and will not stay up.The tech's head got hit by the cover and they have a bruise on their head.Upon evaluation, no medicine or pain medication was administered and nothing was broken.The following information was provided by the initial reporter: customer reports that the barcoda cover is slamming shut and a tech got hurt while working on barcoda.Per customer the lock macanizan mulfunctioning will not stay up.Customer wanted to have fse take a look at it before it becomes physical hazard.Tech's head got hit by the cover and have bruise on her/his head.Upon evaluation, no medicine or pain medication was administered and nothing was broken.
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.
Additional Manufacturer Narrative
H.6 investigation summary customer reported barcoda lid was slamming shut on bd kiestra inoqula (material: 447202, serial number: (b)(6)) that caused a lid hitting laboratory technicians head.Bd technical services inspected the instrument and found that gas springs holding the barcoda lid were weak.This has confirmed the complaint.Bd technical service replaced the faulty springs and resolved the instrument issue.Customer confirmed that this issue caused bruising on technicians head however, no medical intervention, no broken skin or bones and no medication, including pain management medication, were administrated.This is a known issue investigated under situation analyses and corrective and preventative action (capa).Root cause is defined as faulty springs, and replacement with new set is initiated as a corrective action.Design history record (dhr) review is not required for this complaint, the complaint was evaluated via other elements of the investigation.The results of this evaluation have not identified any new hazards, new risks, or specific trends.Bd quality will continue to closely monitor for trends associated with this issue.
Event or Problem Description
It was reported that while using the bd kiestra inoqula the cover is slamming shut and a tech got hurt while working on the barcoda.Per customer the lock is malfunctioning and will not stay up.The tech's head got hit by the cover and they have a bruise on their head.Upon evaluation, no medicine or pain medication was administered and nothing was broken.The following information was provided by the initial reporter: customer reports that the barcoda cover is slamming shut and a tech got hurt while working on barcoda.Per customer the lock macanizan malfunctioning will not stay up.Customer wanted to have fse take a look at it before it becomes physical hazard.Tech's head got hit by the cover and have bruise on her/his head.Upon evaluation, no medicine or pain medication was administered and nothing was broken.

• Brand Name: BD KIESTRA INOQULA
• Common Device Name: UNKNOWN
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15577847
• Report Number: 1119779-2022-01286
• Device Sequence Number: 12604515
• Product Code: JTC
• UDI-Device Identifier: 00382904472023
• UDI-Public: 00382904472023
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 447202
• Device Catalogue Number: 447202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown