MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TIP CAPS,LUER SLIP,STER,YEL, 1; DISPENSER, LIQUID MEDICATION

Catalog Number H93866100

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

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

Event Type  malfunction  

Manufacturer Narrative

Event date: this event occurred during the unspecified date of (b)(6) 2021.Initial reporter postal code: (b)(6).Initial reporter address - (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unknown contamination was found in a discpac self-righting luer slip tip cap (yellow) 100 ct.The issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4, h6 and h10.H4: device manufactured between november 16, 2020 to november 17, 2020.H10: the device was received for evaluation.Unaided eye visual inspection was done which observed a dark foreign matter on the inside diameter of the tip cap.Under magnification, the particulate matter was found to be embedded around the outside and inside of the barrel areas of the tip cap.The reported condition was verified.The cause of the condition could not be determined.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: TIP CAPS,LUER SLIP,STER,YEL, 1
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12543834
• MDR Text Key: 273692475
• Report Number: 1416980-2021-05981
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 00085412478852
• UDI-Public: (01)00085412478852
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H93866100
• Device Lot Number: 60268610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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