MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STERILE EMED DISPENSING PIN; SYRINGE, PISTON

Catalog Number	H93847
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was discovered either on (b)(6)2022 or (b)(6)2022.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of dispensing pins had clear residue on the pin itself.The residue was further described "more of an oil-based clear lubricant coating the product".This issue was identified before use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured from march 16, 2022 - march 17, 2022.H10: one (1) opened and two (2) unopened samples were received for evaluation.Unaided visual inspection was performed which observed a thin layer of silicone liquid between the inlet spike and the cap of the opened and unopened samples.This is not considered a defect as medical grade silicone fluid is required by this product for proper assembly and functionality and no excess silicone was observed.Therefore, the reported condition was not verified.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: STERILE EMED DISPENSING PIN
• Common Device Name: SYRINGE, PISTON
• 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: 15555282
• Report Number: 1416980-2022-04960
• Device Sequence Number: 17785964
• Product Code: FMF
• UDI-Device Identifier: 00085412476575
• UDI-Public: (01)00085412476575
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K872743
• 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): 10/27/2022

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: Other
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: H93847
• Device Lot Number: 60355125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown