MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number 04U42-84

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/07/2021

Event Type  Injury  

Event Description

While working with the autoloader, an abbott employee scratched his finger with the closed mode needle, which broke the glove and resulted in reddened skin, however no blood was observed.The wound was sanitized with soap and water and alcohol.Anti-hiv therapy was given to prevent infection.

Manufacturer Narrative

No patient involved; event involved company representative.No demographic information is available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The part within the cell-dyn ruby system that the employee came into contact with was cd ruby asp ndl, part number 09h06-01 the investigation included review of product historical data, and product labeling.Review of product historical data did not identify any trends and no abnormal complaint activity was observed.It was determined that use error contributed to the issue as the service manual states, ¿probes, needles, aspiration probes are sharp and potentially contaminated with infectious materials.Avoid contact with the tips of these parts.¿ based on the investigation, no product deficiency was identified for the cd ruby asp ndl, part number 09h06-01 for the complaint issue; the device met performance specifications and performed as intended at the customer site.

• Brand Name: CELL-DYN RUBY SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12677088
• MDR Text Key: 282973557
• Report Number: 2919069-2021-00021
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 04U42-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/12/2021
• Supplement Dates FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention