MAUDE Adverse Event Report: BD INSYTE-N¿ IV CATHETER 24GA 0.56IN; INTRAVASCULAR CATHETER

Model Number	381211
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 bd insyte-n¿ iv catheters 24ga 0.56in experienced a needle that pierced through the needle cover.The following information was provided by the initial reporter: nurses and registrar noted on preparing for iv cannular insertion, bd insyte-n 24 ga 14mm, that the needles were going through the side of the plastic sleeve, also one we opened had a right angle bend at its tip.Registrar went to insert iv cannular into 3month old baby, but the guiding needle had gone out the side of plastic sleeve (part that is left in vein) this prickled skin but could not be advanced so failed and had to re-cannulate.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.
Event or Problem Description
It was reported that 2 bd insyte-n¿ iv catheters 24ga 0.56in experienced a needle that pierced through the needle cover.The following information was provided by the initial reporter: nurses and registrar noted on preparing for iv cannular insertion, bd insyte-n 24 ga 14mm, that the needles were going through the side of the plastic sleeve, also one we opened had a right angle bend at its tip.Registrar went to insert iv cannular into 3month old baby, but the guiding needle had gone out the side of plastic sleeve (part that is left in vein) this prickled skin but could not be advanced so failed and had to re-cannulate.

• Brand Name: BD INSYTE-N¿ IV CATHETER 24GA 0.56IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12316669
• Report Number: 8041187-2021-00719
• Device Sequence Number: 4672146
• Product Code: FOZ
• UDI-Device Identifier: 30382903812111
• UDI-Public: 30382903812111
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: Other
• Device Model Number: 381211
• Device Catalogue Number: 381211
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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