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 Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of 126149 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "the io went in as usual, but when they went to flush it the port at the 90-degree elbow blew out and spray the paramedic in the face.Per my investigation the port at the 90-degree elbow was not touched with a syringe prior to the failure and did not look out of the ordinary when the paramedic attached it to the io in the extremity.".
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 valve failure was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one intraosseous needle kit extension set.The blue valve septum was completely removed from the valve housing and was received loose.The valve and valve housing components appeared well-formed.Microscopic inspection of the sample components confirmed that they were well-formed and unremarkable.Attempts to insert the valve septum into the housing were unsuccessful as the septum retention figure was too wide to fit through top of the valve housing.The valve components appeared to be well-formed, suggesting that the observed valve septum separation was caused by initial improper assembly.The device is a supplied component and the supplier has been notified of this event.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by the customer "the io went in as usual, but when they went to flush it the port at the 90-degree elbow blew out and spray the paramedic in the face.Per my investigation the port at the 90-degree elbow was not touched with a syringe prior to the failure and did not look out of the ordinary when the paramedic attached it to the io in the extremity." additional information recieved: were there any adverse reactions to the exposed area (redness, swelling, tingling, burning, etc.)? no, but unable to administer medications.Was there patient exposure? yes.Was there a delay in the patient¿s medical treatment because of the exposure? yes.Was medical treatment provided to the healthcare worker and if so, what was done? yes, exposure to bodily fluids report and evaluation.Was additional medical treatment provided to the patient and if so, what was done? cardiac arrest, treated the patient.Nothing more because of the failure.

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15121945
• Report Number: 3006260740-2022-02915
• Device Sequence Number: 20245509
• Product Code: FMI
• UDI-Device Identifier: 00801741163678
• UDI-Public: (01)00801741163678
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 126149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 11/15/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown