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	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
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 126178 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (126178) have been reported from the same facility.
Event or Problem Description
It was reported "io needle failure recently.Needle bent during the insertion.Paramedic was on 793 on friday, (b)(6) 2022.He went to insert a 25 mm gauge io (blue) into the proximal tibia on a pt in cardiac arrest.Paramedic reported with minimal pressure applied during the procedure, the io needle bent, resulting in aborting further attempt at insertion of that particular io needle.".
Event or Problem Description
It was reported "io needle failure recently.Needle bent during the insertion.Paramedic was on 793 on friday, 5-20-2022.He went to insert a 25 mm gauge io (blue) into the proximal tibia on a pt in cardiac arrest.Paramedic reported with minimal pressure applied during the procedure, the io needle bent, resulting in aborting further attempt at insertion of that particular io needle.".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent intraosseous needle is confirmed; however, the exact cause is unknown.One photograph of a 25 mm intraosseous needle was returned for evaluation.An initial visual observation of the photograph showed the needle cannula and stylet within were bent at the base of the needle.No blood residue could be seen on the sample in the returned photograph.No further damage or other details could be seen on the sample in the returned photograph.While the exact cause of the bent needle in the returned photograph could not be determined, possible contributing factors include force applied during storage, handling, or use and forceful insertion against resistance.
Additional Manufacturer Narrative
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 "io needle failure recently.Needle bent during the insertion.Paramedic was on 793 on friday, (b)(6) 2022.He went to insert a 25 mm gauge io (blue) into the proximal tibia on a pt in cardiac arrest.Paramedic reported with minimal pressure applied during the procedure, the io needle bent, resulting in aborting further attempt at insertion of that particular io needle.".

• 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: 14734828
• Report Number: 3006260740-2022-02329
• Device Sequence Number: 2350473
• Product Code: FMI
• UDI-Device Identifier: 00801741163678
• UDI-Public: (01)00801741163678
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 10/11/2022

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: 126178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/06/2022; 10/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/18/2022; 12/27/2022
• 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