MAUDE Adverse Event Report: UNOMEDICAL A/S ACCUCHEK TENDERLINK; AC TENDERLINK I 17/60 10PCS.

Model Number	04541642001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.The information in this complaint (b)(4) has been evaluated.The batch 6005218 in question was manufactured at the (b)(4) site.Investigation process of the complaint was carried out in accordance with work instruction guideline for test of ref.Samples buid-umd version 11 for the code leakage from infusion site (cannula base part/cannula) (specific cause not identified).Complaint investigations.Three unused sets were provided and there are no visible damages or defects.The following tests were performed: visual inspection according to with work instruction version 9, 3 unused sets passed.Functional test 1 according to work instruction version 10 on 3 unused sets, 3 samples out 3 samples passed the test.Functional test 2 according to work instruction version 44 on 3 unused sets, 3 samples out 3 samples passed the test.A batch record review was conducted resulting in the following: the lot 6005218 was manufactured according to the device history record (dhr) 4902056 version 16 on the multivac 14, on 30/jan/2024, with a total of (b)(4) units.Review of the device history record (dhr) showed that all relevant tests required during the related process had been fulfilled and met the requirements.A query was run in trackwise against malfunction code leakage from infusion site (cannula base part/cannula) (specific cause not identified) and lot 6005218 and no other complaint has been registered in tw since the last 12 months.Conclusion summary of the related event: as a result of the following: based on the investigation and test results the malfunction reported cannot be confirmed on the samples returned, no harm reported, no non-conformance (nc) raised during production, no other complaint received on the lot in question, no further actions are required.Therefore, this issue will be monitored through the post marketing surveillance (pms) product trends and malfunction according to the market quality review (mqr) procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in netherlands.It was reported that patient faced infusion set cannula leaking event on (b)(6) 2024.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: netherlands.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted expiration date under d4 and manufacturing date under h4.Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: the information in this complaint (b)(4) has been evaluated.The batch 6005218 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guidance for visual testing for complaints area version 3 and wi guidance for functional testing for complaints area version 2 for the code leakage from infusion site (cannula base part/cannula) (specific cause not identified).Investigation process of the complaint was carried out in accordance with wi guideline for test of ref.Samples version 11 for the code leakage from infusion site (cannula base part/cannula) (specific cause not identified).Test results: complaint investigations.Three unused sets were provided and there are no visible damages or defects.The following tests were performed: visual inspection according to with wi version 9, 3 unused sets passed.Functional test 1 according to wi version 10 on 3 unused sets, 3 samples out 3 samples passed the test.Functional test 2 according to wi version 44 on 3 unused sets, 3 samples out 3 samples passed the test.Visual test according to wi version 3 on reference samples, 10 samples out 10 samples passed the test.Functional test air flow according to wi version 2 on reference samples, 10 samples out 10 samples passed the test.Functional test under water leak according to wi version 2 on reference samples, 10 samples out 10 samples passed the test.Device history record (dhr) review: packaging: a batch record review was conducted resulting in the following: the lot 6005218 was manufactured according to the wi version 16 on the multivac 14, on 30/jan/2024, with a total of (b)(4) units.Assembly cannula: the lot 4a04677 was assembled according to wi version 14 in the machine lc04, on 21/jan/2024, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related process had been fulfilled and met the requirements.Trending: a query was run in database on 27/jun/2025 against malfunction code leakage from infusion site (cannula base part/cannula) (specific cause not identified) and lot 6005218 and no other complaints has been registered in database for the same lot and malfunction code.Conclusion summary of the related event: as a result of the following: no defect on tests for reference samples, no non-conformance (nc) raised during production related to complaint code, only one complaint received on the lot in question and malfunction code, no further actions are required.This complaint will not require further root cause investigation nor capa plan.Therefore, this issue will be monitored through the post market surveillance activities.

• Brand Name: ACCUCHEK TENDERLINK
• Common Device Name: AC TENDERLINK I 17/60 10PCS.
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20662668
• Report Number: 3003442380-2024-29784
• Device Sequence Number: 18268419
• Product Code: FPA
• UDI-Device Identifier: 05705244008656
• UDI-Public: 05705244008656
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2025

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: Lay User/Patient
• Device Model Number: 04541642001
• Device Lot Number: 6005218
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 07/07/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/17/2024; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female