MAUDE Adverse Event Report: COOK INC INTRAOSSEOUS INFUSION NEEDLE; FMI NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	C-DIN-18-3.0-T45
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The customer was unable to gain iv access for a dehydrated infant.It was reported that they had 3 intraosseous needle would not penetrate patient¿s bone (1 from lot 4477456 this mfr and 2 from related mfr #1820334-2018-03827).The patient was stabilized with other means and forced fluids.It was further reported that the patient "perked up" and that the outcome was favorable and the patient was transferred to another hospital.No other information was made available.

• Brand Name: INTRAOSSEOUS INFUSION NEEDLE
• Common Device Name: FMI NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8171166
• Report Number: 1820334-2018-03828
• Device Sequence Number: 1333189
• Product Code: FMI
• UDI-Device Identifier: 00827002044319
• UDI-Public: (01)00827002044319(17)180801(10)4477456
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: C-DIN-18-3.0-T45
• Device Lot Number: 4477456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1