MAUDE Adverse Event Report: BD¿ PRN ADAPTER; INTERVASCULAR CATHETER

Catalog Number	385110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: in response to the event reported, a device history review was conducted for lot number 0322470.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately due to current practices being implemented by (b)(6) customs, used medical device cannot be submitted to the manufacturing facility for functional testing.Photographs of the devices were submitted and functional testing was performed on retention samples for the affected lot.Leaks were observed in some of the retention samples; closer inspection revealed that in all instances where a device had leaked the heparin cap had been inserted into the connector loosely, reinsertion of the heparin cap allowed all of the devices to function normally without developing further leaks.Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review.The plant has started capa#(b)(4) in december 2020 to conduct an in-depth investigation.One of the measures was to improve the taper of the adapter, which was completed in december 2021.The complaint sample was produced before the base was improved.
Event or Problem Description
It was reported that the bd¿ prn adapter leaked anticancer medication onto the animal's skin during the infusion.The following information was provided by the initial reporter, translated from (b)(6) to english: "during infusion of an anticancer drug for a pet, the leakage occurred.After i placed a needle/catheter and connected it to prn and started infusion and then saw the fluid leaking between the intravenous cannula and the prn adapter, which caused a damage on the animal skin.".

• Brand Name: BD¿ PRN ADAPTER
• Common Device Name: INTERVASCULAR CATHETER
• MDR Report Key: 12593864
• Report Number: 3014704491-2021-00188
• Device Sequence Number: 11618486
• Product Code: FPA
• UDI-Device Identifier: 00382903851102
• UDI-Public: 00382903851102
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K933467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 12/17/2024
• Device Catalogue Number: 385110
• Device Lot Number: 0322470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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