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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
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 127808 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the luer nut on the extension set is very "sticky" and tough to adjust and attach to the needle." 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 a ¿sticky¿ luer adapter was confirmed; however, the root cause was not identified.The product returned for evaluation was one intraosseous (io) needle extension set.Light usage residues were observed within the male luer adapter.Attachment of the extension set to non-complainant accessories was successful and unremarkable.Attempts to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed at the connection points with non-complainant accessories.Tactile inspection of the sample revealed resistance when manipulating the male luer adapter locking collar.Microscopic inspection of the sample confirmed white crystalline residue within the male luer adapter.Some resistance was encountered when manipulating the male luer adapter locking collar; however, the exact root cause of that resistance was not identified.It appeared that residue accumulation within the luer adapter may have contributed.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "the luer nut on the extension set is very "sticky" and tough to adjust and attach to the needle." no other information was provided.

• 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: 14307596
• Report Number: 3006260740-2022-01632
• Device Sequence Number: 20077592
• Product Code: FMI
• UDI-Device Identifier: 00801741163609
• UDI-Public: (01)00801741163609
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: D015451NK
• Device Lot Number: 127808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 08/18/2022
• 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