MAUDE Adverse Event Report: IV SET AN122 W/O PUMP T-TYPE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 59011533

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

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).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 that the iv set an122 w/o pump t-type experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: foreign substances in tube.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-28.H6: investigation summary a device history review was conducted for lot number 2104233.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, a sample was provided to aid in our investigation.Our engineers were able observe foreign material located within the tubing.The reported event has been confirmed.Compositional testing of the foreign material positively identified it as a latex.The latex is most likely originating from the vial rubber, which was damaged during puncture of the iv spike.H3 other text : see h10.

Event Description

It was reported that the iv set an122 w/o pump t-type experienced foreign matter in the fluid pathway.The following information was provided by the initial reporter: foreign substances in tube.

• Brand Name: IV SET AN122 W/O PUMP T-TYPE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12331941
• MDR Text Key: 266936856
• Report Number: 2243072-2021-02084
• 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: 10/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/22/2024
• Device Catalogue Number: 59011533
• Device Lot Number: 2104233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 10/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• 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