MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW BIOPSY

Catalog Number DIN1515X

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

Pr # (b)(4).A follow up submission will be done upon completion of carefusion's investigation or additional information becomes available.

Event Description

¿during incoming visual inspection at (b)(4) - (15 out of 360) packages were found to be unsealed, therefore sterility compromised.¿.

Manufacturer Narrative

(b)(4) upon further evaluation it has been determined this event did not meet the requirements for emdr reporting.As the issue reported was found and received while product was still in control of bd.To date, bd has not received any further reports from direct customers with this failure.Bd is performing further investigation on this internal finding.Bd will continue to monitor and provide follow up emdr as applicable.

• Brand Name: ILLINOIS NEEDLE BONE MARROW BIOPSY
• Type of Device: BONE MARROW BIOPSY
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 7128647
• MDR Text Key: 95829895
• Report Number: 9680904-2017-00229
• Device Sequence Number: 1
• Product Code: FSH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K813338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

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 Expiration Date: 04/04/2022
• Device Catalogue Number: DIN1515X
• Device Lot Number: 0001097560
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 11/24/2017
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other