MAUDE Adverse Event Report: PRN LUER SLIP ADAPTER .75IN INJ SITE; INTERVASCULAR CATHETER

Catalog Number	385110
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that prn luer slip adapter.75in inj site was damaged.The following information was provided by the initial reporter: this is a report about suspected product deterioration.The rubber part of prn adapter was discolored and hard.This might be due to storage conditions but we didn't use the complaint product from a safety standpoint.
Event or Problem Description
It was reported that prn luer slip adapter.75in inj site was damaged.The following information was provided by the initial reporter: this is a report about suspected product deterioration.The rubber part of prn adapter was discolored and hard.This might be due to storage conditions but we didn't use the complaint product from a safety standpoint.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 8/31/2021.H6: investigation: a device history review was conducted for lot number 7227138.Our records show that this is the only instance of this issue occurring in this production batch.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.Additionally the sample that was submitted by the facility has been reviewed by our team of quality engineers.Based on their assessment of the discoloration, they were able to determine that the most likely root cause for this event is related to storage or transportation.Advanced aging such as this is most likely the result of exposure to extremely humid or otherwise oxidizing environments.Inspection of the retained samples for this lot did not exhibit any additional instances of this or any other observable non-conformances.

• Brand Name: PRN LUER SLIP ADAPTER .75IN INJ SITE
• Common Device Name: INTERVASCULAR CATHETER
• MDR Report Key: 12264055
• Report Number: 3014704491-2021-00061
• Device Sequence Number: 2695841
• Product Code: FOZ
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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: 08/31/2021
• Device Catalogue Number: 385110
• Device Lot Number: 7227138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2017
• 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