MAUDE Adverse Event Report: INTEGRA - PRINCETON INTEGRA RESERVOIR 2.5CM DOME,FLAT BOTTOM, SIDE I; N/A

Catalog Number	NL8501212
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the bottom of the integra reservoir 2.5cm dome,flat bottom, side i (nl8501212) was punctured with a port needle (<22g) during puncture.Therefore, the reservoir had to be explanted.There was increased surgery time of an hour (time from indicating the perforation in the or until explantation and implantation of a new device).There was no patient harm.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Integra reservoir (nl8501212) was returned for evaluation: device history record (dhr) - the dhr documentation was reviewed and no anomalies during the manufacture and packaging process that could be related to the reported condition was observed.Failure analysis: the unit was visually inspected, and no manufacturing defect was observed.Upon closer inspection it was observed that the polypropylene needle-puncture shield was perforated.The dome was inspected with a magnifying camera and no punctures were observed on the dome area (top of reservoir); however, two (2) punctures were observed on the bottom flat surface of the reservoir.Since it was unexpected to find punctures at the bottom of the reservoir and none on the dome, an experiment was made with water to confirm what was observed.Water was introduced into the reservoir through the reservoir¿s inlet using a needle connected to a piece of catheter.Once the air was removed and the reservoir was filled with water, pressure was applied with the syringe and water leaked from the two (2) punctures at the bottom of the reservoir.No water leaks (punctures) were observed on the reservoir dome (top of reservoir).Therefore, it is confirmed that the user punctured the reservoir on the bottom side of the reservoir instead of the dome.Root cause: after evaluating the reservoir, it was confirmed that the user punctured the reservoir through the flat bottom side of the reservoir instead of the dome.No punctures were found on the dome (top side) of the reservoir.It was also observed that the ¿polypropylene needle-puncture shield¿ was perforated.It is unknown if the shield was perforated by accident or on purpose to gain access to the reservoir since it was accessed from the bottom side of the reservoir.Therefore, the reported condition was confirmed, and the root cause is related to a use error.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: INTEGRA RESERVOIR 2.5CM DOME,FLAT BOTTOM, SIDE I
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18108109
• Report Number: 3003418325-2023-00017
• Device Sequence Number: 6874805
• Product Code: JXG
• UDI-Device Identifier: 10381780024217
• UDI-Public: 10381780024217
• Combination Product (Y/N): N
• PMA/510(K) Number: K153041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NL8501212
• Device Lot Number: 6889315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2023
• 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 Sex: Unknown