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

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported ¿we had to use pliers to remove the io needle from the training leg.We could not remove the needle with our hands.¿ no other information was provided.

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 bent intraosseous needle was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting an intraosseous needle.The depicted needle exhibited a bend near the exit site from the luer adapter.The tip of the needle exhibited deformation.While needle damage was apparent in the submitted photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The tip deformation suggested that attempted insertion against resistance may have contributed.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported ¿we had to use pliers to remove the io needle from the training leg.We could not remove the needle with our hands.¿ no other information was provided.Additional info.Received: "this needle was used during a training session with insertion into the proximal tibial tuberosity site of an adult io training leg.We had difficulty removing the style once the needle was inserted.Once we were able to remove style and complete the training, we then had significant difficulty removing the needle from the training leg.We had to resort to using pliers which damaged the needle.".

• Brand Name: BD INTRAOSSEOUS NEEDLE KIT
• Type of Device: 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: 13419399
• MDR Text Key: 285399315
• Report Number: 3006260740-2022-00129
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other