MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE PNK 20GA X 1.88IN; INTRAVASCULAR CATHETER

Catalog Number	381237
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our quality engineer inspected the four samples submitted for evaluation.The reported issue of threading difficult was not confirmed upon inspection of the samples, however needle through catheter was confirmed.Analysis of the samples showed a ¿v¿ cut on the catheter tubing near the tip area on the two samples of known lots.The unknow lot samples had no damages or defects observed.The two samples of the unknown lot were also subjected to a penetration and drag test and both samples were within specification and passed the tests.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.From returned samples, observed needle pierced through catheter or a ¿v-cut¿ on the catheter that matches the shape of the bevel.The assembly process was reviewed.If the needle pierced through the catheter during the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.The defect could happen during product application, when the product was manipulated, or during needle cover removal.As the samples were returned in open packaging, the actual root cause could not be established.As current control, there is outgoing inspection and hourly in-process inspection in place to check for needles that have pierced through the catheter.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
It was reported that bd insyte pnk 20ga x 1.88in needle through catheter while introducing catheter after puncturing the blood vessel, advancing the infusion tube is more difficult than before.This now also often causes more pain to the patient.The infusionist feels that the current infusion tubes are stiffer than before, and that more resistance can also be felt when sliding and inserting the infusion.The infusion needles from the previous batch no.2328939 did not give these problems.

• Brand Name: BD INSYTE PNK 20GA X 1.88IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19909659
• Report Number: 2243072-2024-00854
• Device Sequence Number: 8752052
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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 Catalogue Number: 381237
• Device Lot Number: 2328939
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown