MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX NEEDLE PORT ADAPTER; SET, I.V. FLUID TRANSFER

Catalog Number	H93867
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two (2) "cartons" (packaging) of needle port adapters external thread were contaminated.The event was further described as ¿the primary packaging is partially transparent at the edges, i.E.At the points where the plastic film is glued to the paper¿.Further stating that ¿as per previous purchase, entire primary packaging is white on the back¿.This issue was identified prior to use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: fifty (50) devices were received for evaluation.Unaided eye visual inspection was done which observed partial darkened/transparent areas around the sealed section of both sides of the primary packaging label with all samples.The reported condition was verified.The cause of the condition was due to a manufacturing issue.The issue was likely due to over-sealing / over-welding in the manufacturing process.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: EXACTAMIX NEEDLE PORT ADAPTER
• Common Device Name: SET, I.V. FLUID TRANSFER
• 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: 12911133
• Report Number: 1416980-2021-07067
• Device Sequence Number: 4819937
• Product Code: LHI
• UDI-Device Identifier: 05413765562730
• UDI-Public: (01)05413765562730
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K903159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: H93867
• Device Lot Number: 60262816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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
• Patient Sex: Unknown