MAUDE Adverse Event Report: INSYTE PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381234
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date received by manufacturer: bd was initially made aware of this complaint on 2021-06-25.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional investigational information was later received on 2021-09-10 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.Investigation summary: one sample with open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection to check for catheter damage.From the returned sample, the needle pierced through the catheter tip was observed.No cannula bevel damage was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the verbatim, ¿the catheter had been checked prior to use, and no problems were noted¿, this defect occurred outside of the manufacturing facility.Needle pierced through the catheter can also occur during insertion when the product is manipulated.As the sample was opened and used, the actual root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that insyte pnk 20ga x 1.16in needle went through the catheter.The following information was provided by the initial reporter: patient came in for a blood test.The patient had thicker/harder skin.When penetrating the skin, the catheter deformed, turned over and only the needle was inserted.This caused the patient pain.The catheter had been checked prior to use, and no problems were noted.Local pain on puncture.From investigation: "one sample with open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection to check for catheter damage.From the returned sample, the needle pierced through the catheter tip was observed.No cannula bevel damage was observed.".

• Brand Name: INSYTE PNK 20GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12467655
• Report Number: 8041187-2021-00834
• Device Sequence Number: 19781689
• Product Code: FOZ
• UDI-Device Identifier: 00382903812349
• UDI-Public: 00382903812349
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• 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 Expiration Date: 04/30/2024
• Device Catalogue Number: 381234
• Device Lot Number: 9109988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2019
• 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