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

Catalog Number 447204

Device Problem Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown."the field service engineer reported on the instrument bd kiestra inoqula wca (material # 447204 - serial # (b)(4)) that the two cylinders of the barcoda cover could no longer hold it and there was a risk of falling on someone's head during printer maintenance.The field service engineer replaced the cylinders and did a functional check of the entire ras chain.The issue that the two cylinders of the barcoda cover could no longer hold it was confirmed by the field service engineer.Corrective and preventive action (capa) and situation analysis (sa) have been opened for the investigation of corrective actions leading to avoid risks of errors and user injury.This complaint has been included in the capa for traceability of the issue.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 Description

It was reported while testing with bd instrument kiestra inoqula wca the barcoda lid is not properly held up.There was no report of patient impact.The following information was provided by the initial reporter: the two cylinders of the barcoda cover can no longer hold it, risk of falling on someone's head during printer maintenance.

• Brand Name: BD INSTRUMENT KIESTRA INOQULA WCA
• Type of Device: MICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
• 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: 14959610
• MDR Text Key: 304527357
• Report Number: 1119779-2022-00968
• Device Sequence Number: 1
• Product Code: JTC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2022

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
• Device Operator: Other
• Device Catalogue Number: 447204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1