MAUDE Adverse Event Report: PRN ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 388638

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported prn adapter had foreign matter.The following information was provided by the initial reporter, translated from (b)(6): "the nurse prepared to perform the superficial vein indwelling operation for the child.Prepared a disposable prn, checked that the outer packaging is in good condition and not expired.Opened the outer packaging and found the prn.There is a black stain of about 0.05cm×0.05cm in the puncture area of the latex plug, which cannot be used normally.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 0352367.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.

Event Description

It was reported prn adapter had foreign matter.The following information was provided by the initial reporter, translated from chinese: "the nurse prepared to perform the superficial vein indwelling operation for the child.Prepared a disposable prn, checked that the outer packaging is in good condition and not expired.Opened the outer packaging and found the prn.There is a black stain of about 0.05cm×0.05cm in the puncture area of the latex plug, which cannot be used normally.".

• Brand Name: PRN ADAPTER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12485652
• MDR Text Key: 271916697
• Report Number: 3014704491-2021-00141
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/26/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 388638
• Device Lot Number: 0352367
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 09/26/2021
• Supplement Dates FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1