MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BD INTRAOSSEOUS NEEDLE SET KIT 45MM X 15GA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	D015451NK
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by sales rep, "i did a demo today with product and the safety mechanism did not engage." no other information was provided.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 127300 showed one other similar product complaint(s) from this lot number.
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 sales rep, "i did a demo today with product and the safety mechanism did not engage." no other information was provided.
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.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of safety mechanism failure to activate was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 45mm intraosseous needle.The sample was received assembled with the stylet inlaid through the needle.Light usage residues were observed.The stylet was not fully inserted into the needle, leaving a gap between the stylet bevel and needle bevel.A corresponding gap was observed between the needle luer and the stylet housing.Microscopic inspection of the sample confirmed that the stylet was not fully inserted into the needle.The safety mechanism remained within the stylet housing when the stylet was withdrawn from the needle.The safety mechanism functioned as intended following proper assembly of the needle/stylet.The initial failure of the safety mechanism to engage appeared to be caused by the safety mechanism not being properly engaged with the needle luer adapter.It appeared that the components were not properly mated during device assembly.The device is a supplied component and the supplier has been notified of this event.
Event or Problem Description
It was reported by sales rep, "i did a demo today with product and the safety mechanism did not engage." no other information was provided.

• Brand Name: BD INTRAOSSEOUS NEEDLE SET KIT 45MM X 15GA
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14317080
• Report Number: 3006260740-2022-01685
• Device Sequence Number: 4976303
• Product Code: FMI
• UDI-Device Identifier: 00801741163609
• UDI-Public: (01)00801741163609
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: D015451NK
• Device Catalogue Number: D015451NK
• Device Lot Number: 127300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 10/19/2022; 10/03/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 11/15/2022; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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