MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD INTRAOSSEOUS NEEDLE SET KIT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "on (b)(6) 2022 crew responded to a respiratory call which ended up becoming a full arrest.Paramedic used the blue 25mm io needle on the left tibial tuberosity.Once inserted, medic had attempted to remove the needle from the catheter and the entire needle came out along with the catheter.A second attempt was issued on the right tibial tuberosity but with more pressure applied.The needle then came out with no issue and the io was successful.Patient was then treated per treatment guidelines and no other issues were noted on the call.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the customer "on (b)(6) 2022 crew responded to a respiratory call which ended up becoming a full arrest.Paramedic used the blue 25mm io needle on the left tibial tuberosity.Once inserted, medic had attempted to remove the needle from the catheter and the entire needle came out along with the catheter.A second attempt was issued on the right tibial tuberosity but with more pressure applied.The needle then came out with no issue and the io was successful.Patient was then treated per treatment guidelines and no other issues were noted on the call.
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.

• Brand Name: BD INTRAOSSEOUS NEEDLE SET KIT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14978126
• Report Number: 3006260740-2022-02656
• Device Sequence Number: 5098390
• Product Code: FMI
• UDI-Device Identifier: 00801741163678
• UDI-Public: (01)00801741163678
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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 Model Number: N/A
• Device Catalogue Number: D015251NK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 12/22/2022
• 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