MAUDE Adverse Event Report: ACCUCHEK TENDERLINK; AC TENDERLINK I 13/60 10PCS.

Lot Number	5376470
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in poland.The patient's father reported that his child's infusion set's soft cannula melted (it was softer) and it was bent when he took it out.He thinks that this issue occurred due to the weather (35 degrees).No further information was available.

• Brand Name: ACCUCHEK TENDERLINK
• Common Device Name: AC TENDERLINK I 13/60 10PCS.
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 17884204
• Report Number: 3003442380-2023-00352
• Device Sequence Number: 20720800
• Product Code: FPA
• UDI-Device Identifier: 05705244008502
• UDI-Public: 05705244008502
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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
• Device Expiration Date: 12/01/2024
• Device Lot Number: 5376470
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/06/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown