MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. INTRASITE GEL APPLIPAK 15G CTN 10; DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC

Model Number	66027311
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during treatment, it was observed that the tube of some intrasite gel applipak 15g ctn 10 units lacked a cap and tube closure.It was noted that the cream was airborne and therefore not sterile.The number of defective units is unknown.Treatment was completed, without any delay, using a back-up device.No patient injury reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not used for treatment and was not returned for analysis.No photographs were provided in support of this complaint.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.It was reported that, during treatment, it was observed that the tube of some intrasite gel applipak 15g ctn 10 units lacked a cap and tube closure.A manufacturing process review was carried out.There are strict machine and manual checks during the manufacturing process to ensure that products that do not meet specifications are rejected.Probable cause include loss during transport or use.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A review of complaint history did not reveal similar events for the listed batch and part number with no manufacturing problems observed.A review of prior escalation actions found no actions applicable to the scope of this case.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required this investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.Internal complaint reference number: case-2022-00092930-1.

• Brand Name: INTRASITE GEL APPLIPAK 15G CTN 10
• Common Device Name: DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13715192
• Report Number: 8043484-2022-00094
• Device Sequence Number: 20426591
• Product Code: NAE
• UDI-Device Identifier: 00000050223480
• UDI-Public: 00000050223480
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 08/07/2024
• Device Model Number: 66027311
• Device Catalogue Number: 7311
• Device Lot Number: 509562001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2021
• 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