MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN; TRAY, SURGICAL, NEEDLE22

Catalog Number DIN1515X

Device Problem Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Via email: we have recently been receiving concerns regarding the following product: carefusion illinois bone marrow aspiration intraosseous infusion needle.Ref: din1515x.Lot: 0001160301.The concern is the protective tubing covering the sharp is dislodging in the packaging, leaving the sharp exposed.

Event Description

Via email: we have recently been receiving concerns regarding the following product: carefusion illinois bone marrow aspiration intraosseous infusion needle.Ref din1515x.Lot 0001160301.The concern is the protective tubing covering the sharp is dislodging in the packaging, leaving the sharp exposed.

Manufacturer Narrative

(b)(4) follow emdr for device evaluation.One photo and one physical sample were provided to our quality team for evaluation.Upon inspecting the product, the protective needle cover is observed loose inside the sealed pouch, verifying the reported failure.A review of the internal manufacturing device record and raw material history files for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.Previously the packaging process was automated, and it was identified that the machines pressing process could result in the detachment of the needle cover.Currently the process is completely manually, allowing each product to be evaluated, the reported lot was manufactured prior to the new process being implemented.Based on the quality team's investigation, the root cause is determined to be related to previous packaging process and manufacturing equipment.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter will be helpful in trend identification, driving appropriate corrective actions and supporting our commitment to continuous quality improvement h3 other text : see manufacturer narrative.

• Brand Name: ILLINOIS NEEDLE BONE MARROW 15G ADJ LEN
• Type of Device: TRAY, SURGICAL, NEEDLE22
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 9353947
• MDR Text Key: 217369281
• Report Number: 9680904-2019-00022
• 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: consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: DIN1515X
• Device Lot Number: 0001160301
• Date Manufacturer Received: 01/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other