MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD INTRAOSSEOUS VASCULAR ACCESS SYSTEM; BD INTRAOSSEOUS NEEDLE SET KIT

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "incident occurred on newborn baby in operating room after mother gave birth via caesarean section.Newborn was transferred to a facility." customer shared that a 15mm io needle was used.No other information was provided.Adverse impact to patient is unknown at this time.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of 128778 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (128778) have been reported from the same facility in canada.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by the customer "incident of safety mechanism issue and difficulty removing the stylet from the needle occurred on newborn baby in operating room after mother gave birth via caesarean section.Customer shared that a 15mm io needle was used.No other information was provided.Adverse impact to patient is unknown at this time.

• Brand Name: BD INTRAOSSEOUS VASCULAR ACCESS SYSTEM
• Common Device Name: BD INTRAOSSEOUS NEEDLE SET KIT
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15255396
• Report Number: 3006260740-2022-03225
• Device Sequence Number: 14924389
• Product Code: FMI
• UDI-Device Identifier: 00801741163586
• UDI-Public: (01)00801741163586
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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: 12/06/2024
• Device Model Number: N/A
• Device Catalogue Number: D015151NK
• Device Lot Number: 128778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1397-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown