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

Catalog Number DIN1515X

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 01/06/2020

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

Damaged/defective seal.

Manufacturer Narrative

(b)(4) -follow up emdr for device evaluation.Four photo samples were provided to our quality team for investigation.Three of the photos point to where the failure occurred and a hole in the pouches can be observed.Based on the inspection performed, the failure mode could be confirmed.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.It was confirmed that procedural and functional requirements needed for its release were met.Based on the quality team's investigation, the root cause of this incident has not yet been determined.A project has been opened to further investigate and address this incident.H3 other text : see manufacturer narrative.

Event Description

Damaged/defective seal.

• Brand Name: ILLINOIS NEEDLE BONE MARROW 15G ADJ LE
• Type of Device: TRAY, SURGICAL, NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 9654553
• MDR Text Key: 199247885
• Report Number: 9680904-2020-00003
• 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: distributor,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DIN1515X
• Device Lot Number: 0001314966
• Date Manufacturer Received: 01/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other