MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CYSTOSCOPY IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number JC4040

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was particulate matter in a cysto/bladder irrigation set.The reporter stated that after the packaging was opened and the medication spiked, a small piece of red plastic was noted in the chamber.Upon further inspection, the customer noticed that the red cap over the spike was split and a small piece was missing.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed and a small piece of red plastic was observed inside the chamber or housing.A spectrophotometric comparison was performed on the particulate matter and it was determined to of the same material as a component.The reported condition was verified.The cause of the reported condition was an assembly issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CYSTOSCOPY IRRIGATION SET
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7573241
• MDR Text Key: 110368131
• Report Number: 1416980-2018-03436
• Device Sequence Number: 1
• Product Code: LJH
• UDI-Device Identifier: 00085412042695
• UDI-Public: (01)00085412042695
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: JC4040
• Device Lot Number: R17I07023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1