MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW; BIOPSY NEEDLES & TRAYS

Catalog Number DIN1515X

Device Problem Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up emdr submission will be completed upon completion of investigation or if additional information becomes available.

Event Description

Labeling abnormality on 11 needles for sternal puncture of the same lot.The stated expiry date is 27/02/2021 and the manufacturing date of 30/03/2030.

Manufacturer Narrative

(b)(4) our quality engineers received one photo from lot #0000919888 for evaluation.Failure mode could be confirmed since the manufacturing date printed was incorrect according to product code/batch.The investigation concluded the root cause could be related to the manufacturing process and methods.We have since opened up a capa and during the sampling review process, bd verified the expiration and manufacturing date on labels were accurate.The failure mode will be entered into the complaint management system and will be tracked / trended for any additional similar failure modes.Customer complaint trends are evaluated on a monthly basis during our quality team meeting.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: ILLINOIS NEEDLE BONE MARROW
• Type of Device: BIOPSY NEEDLES & TRAYS
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 7277593
• MDR Text Key: 100541756
• Report Number: 9680904-2018-00002
• Device Sequence Number: 1
• Product Code: FSH
• Combination Product (y/n): N
• PMA/PMN Number: K813338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

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: 02/27/2021
• Device Catalogue Number: DIN1515X
• Device Lot Number: 0000919888
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other